Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls

Verani, Jennifer R.; Baqui, Abdullah H.; Broome, Claire V.; Cherian, Thomas; Cohen, Cheryl; Farrar, Jennifer L.; Feikin, Daniel R.; Groome, Michelle J.; Hajjeh, Rana A.; Johnson, Hope L.; Madhi, Shabir A.; Mulholland, Kim; O'Brien, Katherine L.; Parashar, Umesh D.; Patel, Manish M.; Rodrigues, Laura C.; Santosham, Mathuram; Scott, J. Anthony; Smith, Peter G.; Sommerfelt, Halvor; Tate, Jacqueline E.; Victor, J. Chris; Whitney, Cynthia G.; Zaidi, Anita K.; Zell, Elizabeth R.

doi:10.1016/j.vaccine.2017.04.037

Cited by 102Statistical Methods in EpidemiologyVaccine Coverage and HesitancyBacterial Infections and Vaccines

Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls

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Verani, Jennifer R., Baqui, Abdullah H., Broome, Claire V., Cherian, Thomas, Cohen, Cheryl, Farrar, Jennifer L., Feikin, Daniel R., Groome, Michelle J. +17 more·2017·Vaccine

DOI 10.1016/j.vaccine.2017.04.037PMC PMC7007298

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Abstract

Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under 'real world' conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we summarize the recommendations of that group regarding best practices for planning, design and enrollment of cases and controls. Rigorous planning and preparation should focus on understanding the study context including healthcare-seeking and vaccination practices. Case-control vaccine effectiveness studies are best carried out soon after vaccine introduction because high coverage creates strong potential for confounding. Endpoints specific to the vaccine target are preferable to non-specific clinical syndromes since the proportion of non-specific outcomes preventable through vaccination may vary over time and place, leading to potentially confusing results. Controls should be representative of the source population from which cases arise, and are generally recruited from the community or health facilities where cases are enrolled. Matching of controls to cases for potential confounding factors is commonly used, although should be reserved for a limited number of key variables believed to be linked to both vaccination and disease. Case-control vaccine effectiveness studies can provide information useful to guide policy decisions and vaccine development, however rigorous preparation and design is essential.

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Vaccine effectiveness was estimated using the test-negative, case-control study design.
“Vaccine effectiveness was estimated using the test-negative, case–control study design11,12, applying methodology that was developed earlier to assess duration of protection of the BNT162b213 and mRNA-127314 vaccines in the same population during pre-Omicron SARS-CoV-2 infection waves (Methods).”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [12]
Vaccine effectiveness against symptomatic SARS-CoV-2 Omicron infection during the Omicron wave in Qatar was estimated using the test-negative, case-control study design, a standard design for assessing vaccine effectiveness.
“Vaccine effectiveness against symptomatic SARS-CoV-2 Omicron (B.1.1.529)1 infection during the large Omicron wave in Qatar, between December 23, 2021 and February 28, 2022, was estimated using the test-negative, case–control study design, a standard design for assessing vaccine effectiveness11,12,36,40.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [12]
The cohort study design applied earlier to the same population of Qatar yielded findings similar to those of the test-negative case-control design, supporting the validity of this standard approach in assessing vaccine effectiveness.
“However, the cohort study design applied earlier to the same population of Qatar yielded findings similar to those of the test-negative case–control design36,38,39, supporting the validity of this standard approach in assessing vaccine effectiveness11,12,36,40.”
From Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar (2022) · cites this paper as [12]

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Background
Use of surveillance data to estimate the effectiveness of the 7-valent conjugate pneumococcal vaccine in children less than 5 years of age over a 9 year period
Serres, G. D., Pilishvili, T., Link‐Gelles, R., Reingold, A. L., Gershman, K. A., Petit, S., Farley, M. M., Harrison, L. H., Lynfield, R., Bennett, N. M., et al. (2012) · Vaccine · doi:10.1016/j.vaccine.2012.04.017 · Cited by 47 · cited 1× · see citing works
“However, modeling work conducted in conjunction with indirect cohort analyses indicates that while increases in non-vaccine type disease (and carriage) among vaccinated individuals compared with the non-vaccinated can lead to overestimates of VE, the magnitude of the overestimation is relatively small, particularly if…”
MethodSelf-citation
Effectiveness of 7-Valent Pneumococcal Conjugate Vaccine Against Invasive Pneumococcal Disease in HIV-Infected and -Uninfected Children in South Africa: A Matched Case-Control Study
Cohen, C., von Mollendorf, C., de Gouveia, L., Naidoo, N., Meiring, S. T., Quan, V., Nokeri, V., Smit, M. F.-D., Malope‐Kgokong, B., Moore, D. P., et al. (2014) · Clinical Infectious Diseases · doi:10.1093/cid/ciu431 · Cited by 47 · cited 1× · see citing works
“gastroenteritis, pneumonia) are in routine use, and therefore children hospitalized with these illnesses cannot serve as controls, it may be challenging to identify enough eligible hospital controls [31].”
BackgroundSelf-citation
Rotavirus vaccine effectiveness in low-income settings: An evaluation of the test-negative design
Schwartz, L. M., Halloran, M. E., Rowhani‐Rahbar, A., Neuzil, K. M., & Victor, J. C. (2016) · Vaccine · doi:10.1016/j.vaccine.2016.10.077 · Cited by 47 · see citing works
Self-citation
Correlates of vaccine-induced protection: methods and implications
Nguipdop‐Djomo, P., Thomas, S., & Fine, P. (2016) · LSHTM Research Online (London School of Hygiene and Tropical Medicine) · doi:10.17037/pubs.02728969 · Cited by 47 · see citing works
Indirect cohort analysis of 10-valent pneumococcal conjugate vaccine effectiveness against vaccine-type and vaccine-related invasive pneumococcal disease
Verani, J. R., Domingues, C. M. A. S., & de Moraes, J. C. (2015) · Vaccine · doi:10.1016/j.vaccine.2015.10.007 · Cited by 46 · see citing works
Self-citation
Haemophilus influenzae type b conjugate vaccine is highly effective in the Ugandan routine immunization program: a case–control study
Lee, E. H., Lewis, R. F., Makumbi, I., Kekitiinwa, A., Ediamu, T. D., Bazibu, M., Braka, F., Flannery, B. L., ZUBER, P. L. F., & Feikin, D. R. (2008) · Tropical Medicine & International Health · doi:10.1111/j.1365-3156.2008.02027.x · Cited by 44 · see citing works
Self-citation
Effectiveness of Haemophilus influenzae type b vaccination against bacterial pneumonia in Colombia
de la Hoz, F. (2004) · Vaccine · doi:10.1016/j.vaccine.2004.05.017 · Cited by 42 · see citing works
Measuring protection: efficacy versus effectiveness.
Fedson, D. S. (1998) · PubMed · Cited by 40 · see citing works
Health Care-Seeking Behavior During Childhood Diarrheal Illness: Results of Health Care Utilization and Attitudes Surveys of Caretakers in Western Kenya, 2007–2010
Omore, R., O’Reilly, C. E., Williamson, J. M., Moke, F., Were, V. O., Farag, T. H., van Eijk, A. M., Kotloff, K. L., Levine, M. M., Obor, D., et al. (2013) · American Journal of Tropical Medicine and Hygiene · doi:10.4269/ajtmh.12-0755 · Cited by 40 · see citing works
Efficacy of 7-valent pneumococcal conjugate vaccination in Germany: An analysis using the indirect cohort method
Rückinger, S., van der Linden, M., Reinert, R. R., & von Kries, R. (2010) · Vaccine · doi:10.1016/j.vaccine.2010.05.021 · Cited by 38 · see citing works
Putting surveillance data into context: The role of health care utilization surveys in understanding population burden of pneumonia in developing countries
Deutscher, M., Beneden, C. V., Burton, D. C., Shultz, A., Morgan, O. W., Chamany, S., Jordan, H. T., Zhang, X., Flannery, B. L., Feikin, D. R., et al. (2012) · Journal of Epidemiology and Global Health · doi:10.1016/j.jegh.2012.03.001 · Cited by 36 · see citing works
Self-citation
Effectiveness of pneumococcal conjugate vaccine against presumed bacterial pneumonia hospitalisation in HIV-uninfected South African children: a case–control study
Madhi, S. A., Groome, M. J., Zar, H. J., Kapongo, C., Mulligan, C., Nzenze, S. A., Moore, D. P., Zell, E. R., Whitney, C. G., & Verani, J. R. (2015) · Thorax · doi:10.1136/thoraxjnl-2014-206593 · Cited by 35 · see citing works
Self-citation
Health Care Utilization and Symptom Severity in Ghanaian Children – a Cross-Sectional Study
Krumkamp, R., Sarpong, N., Kreuels, B., Ehlkes, L., Loag, W., Schwarz, N. G., Zeeb, H., Adu‐Sarkodie, Y., & May, J. (2013) · PLoS ONE · doi:10.1371/journal.pone.0080598 · Cited by 26 · see citing works
Effectiveness of 7-valent pneumococcal conjugate vaccine in the prevention of invasive pneumococcal disease in children aged 7–59 months. A matched case-control study
Domı́nguez, Á., Ciruela, P., García‐García, J. J., Llop, F. A. M., de Sevilla, M. F., Selva, L., Usandizaga, F. C., Muñoz‐Almagro, C., Planes, A. M., Codina, G., et al. (2011) · Vaccine · doi:10.1016/j.vaccine.2011.09.034 · Cited by 26 · see citing works
Methodology and measurement of the effectiveness of Haemophilus influenzae type b vaccine: Systematic review
O’Loughlin, R. E., Edmond, K. M., Mangtani, P., Cohen, A. L., Shetty, S., Hajjeh, R. A., & Mulholland, K. (2010) · Vaccine · doi:10.1016/j.vaccine.2010.06.107 · Cited by 25 · cited 1× · see citing works
“For example, a systematic review of Hib vaccine effectiveness noted that case-control studies using radiologically confirmed pneumonia endpoints may have overestimated effectiveness (compared to clinical trial estimates of efficacy against that same endpoint), although the reason for the high point estimates is unclea…”
BackgroundSelf-citation
Potential effect of virus interference on influenza vaccine effectiveness estimates in test-negative designs
Suzuki, M., Camacho, A., & Ariyoshi, K. (2014) · Epidemiology and Infection · doi:10.1017/s0950268814000107 · Cited by 21 · see citing works
Effectiveness of the 7-valent pneumococcal conjugate vaccine against vaccine-type invasive disease among children in Uruguay: An evaluation using existing data
Picón, T., Alonso, L., Gabarrot, G. G., Speranza, N., Casas, M., Arrieta, F., Camou, T., Rosa, R., de Oliveira, L. H., & Verani, J. R. (2013) · Vaccine · doi:10.1016/j.vaccine.2013.01.059 · Cited by 21 · see citing works
Self-citation
Haemophilus influenzae type b conjugate vaccine impact against purulent meningitis in Rwanda
Muganga, N., Uwimana, J., FIDELE, N., GAHIMBARE, L., Gessner, B. D., Mueller, J. E., Mhlanga, B. R., Katsande, R., Herbinger, K., & Rugambwa, C. (2007) · Vaccine · doi:10.1016/j.vaccine.2007.06.032 · Cited by 19 · cited 1× · see citing works
“Examples of this approach include: rotavirus-negative gastroenteritis as controls for cases of rotavirus [36,41,43], influenza-negative respiratory infection for cases of influenza [71], pneumococcal or non-purulent/ Hib-negative meningitis as controls for Hib meningitis cases [18,20], and non-vaccine serotype invasiv…”
Background
Impact of Haemophilus influenzae type b conjugate vaccine on bacterial meningitis in the Dominican Republic
Lee, E. H., Corcino, M., Moore, A., Garib, Z., Peña, C., Sánchez, J., Fernández, J., Feris-Iglesias, J. M., & Flannery, B. L. (2008) · Revista Panamericana de Salud Pública · doi:10.1590/s1020-49892008000900002 · Cited by 17 · cited 1× · see citing works
“This method is based on the approach developed for vaccine coverage surveys [15,21,58].”
Method
Effectiveness of Haemophilus influenzae Type b Conjugate Vaccine on Radiologically-Confirmed Pneumonia in Young Children in Pakistan
Khowaja, A. R., Mohiuddin, S., Cohen, A. L., Mirza, W. A., Nadeem, N., Zuberi, T., Salam, B., Mubarak, F., Rizvi, B., Husen, Y. A., et al. (2013) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2013.03.034 · Cited by 14 · cited 1× · see citing works
“Security concerns can also interfere with recruitment of community controls; investigators of Hib vaccine effectiveness in Colombia and Pakistan had to alter control recruitment strategies due to the safety risks associated with seeking neighborhood controls [24,68].”
BackgroundSelf-citation
Selection bias: neighbourhood controls and controls selected from those presenting to a Health Unit in a case control study of efficacy of BCG revaccination
Dantas, O. M. S., Ximenes, R. A. A., de Albuquerque, M. D. F. P., Montarroyos, U. R., de Souza, W. V., Varejão, P., & Rodrigues, L. C. (2007) · BMC Medical Research Methodology · doi:10.1186/1471-2288-7-11 · Cited by 13 · see citing works
Self-citation
Evaluation of the Effectiveness of Haemophilus influenzae Type b Conjugate Vaccine Introduction against Radiologically-Confirmed Hospitalized Pneumonia in Young Children in Ukraine
Pilishvili, T., Chernyshova, L. I., Bondarenko, A. V., Lapii, F., Sychova, I., Cohen, A. L., Flannery, B. L., & Hajjeh, R. A. (2013) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2013.03.025 · Cited by 10 · cited 3× · see citing works
“However, results of a study in such a context are only generalizable to children who would be hospitalized when ill. Controls can also be identified in out-patient clinics that cases would attend if ill [65], an approach used for Hib vaccine effectiveness studies in Colombia [68] and Ukraine [23].”
BackgroundSelf-citation
EFFECTIVENESS OF HAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE FOR PREVENTION OF MENINGITIS IN SENEGAL
Fleming, J. A., Dieye, Y., Ba, O., Mutombo, B. M. W., Diallo, N., Faye, P. C., Bâ, M., Cissé, M. F., Diallo, A. G., Bâ, M., et al. (2010) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0b013e318203aaa0 · Cited by 7 · see citing works

Flagged first, then by citations

2 of the 82 references couldn’t be matched to a known paper.

Research works printed but not linked: 5

[52]Rothman KJ Greenland S Lash TL Modern epidemiology 3rd ed Philadelphia, PA Wolters Kluwer Health/Lippincott Williams & Wilkins 2008
[66]Domingues CMAS Verani J Montenegro Renoiner E de Cunto Brandileone MC Flannery B de Oliveira L Effectiveness of ten-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in Brazil: a matched case-control study Lancet Respirat Med 2014 2 6 464 71 24726406 PMC9003592
[67]Baqui A El Arifeen S Saha S Persson L Zaman K Gessner B Effectiveness of Haemophilus influenzae type B conjugate vaccine on prevention of pneumonia and meningitis in Bangladeshi children: a case-control study Pediatr Infect Dis J 2007 26 7 565 71 17596795
[68]de la Hoz F Higuera A Di Fabio J Luna M Naranjo A de la Luz Valencia Ma Effectiveness of Haemophilus influenzae type b vaccination against bacterial pneumonia in Colombia Vaccine 2004 23 1 36 42 15519705
[84]Rothman KJ Greenland S Lash TL Modern epidemiology 3rd edition Philadelphia, PA Wolters Kluwer Health/Lippincott Williams & Wilkins 2008 168 82

Sorted by citations

Waning of BNT162b2 Vaccine Protection against SARS-CoV-2 Infection in Qatar
Chemaitelly, H., Tang, P., Hasan, M. R., AlMukdad, S., Yassine, H. M., Benslimane, F. M., Al Khatib, H. A., Coyle, P., Ayoub, H. H., Al Kanaani, Z., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2114114 · Cited by 831 · see citing works
Looking beyond COVID-19 vaccine phase 3 trials
Kim, J. H., Marks, F., & Clemens, J. D. (2021) · Nature Medicine · doi:10.1038/s41591-021-01230-y · Cited by 586 · see citing works
Effects of Previous Infection and Vaccination on Symptomatic Omicron Infections
Altarawneh, H. N., Chemaitelly, H., Ayoub, H. H., Tang, P., Hasan, M. R., Yassine, H. M., Al-Khatib, H. A., Smatti, M. K., Coyle, P., Al-Kanaani, Z., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2203965 · Cited by 551 · see citing works
“2 Omicron infection Effectiveness against any symptomatic Omicron infection Cases* (PCR-positive) Controls* (PCR-negative) SMD† Cases* (PCR-positive) Controls* (PCR-negative) SMD† Cases* (PCR-positive) Controls* (PCR-negative) SMD† N= 3,212 N= 3,212 N=10,646 N=10,646 N=13,139 N=13,139 Median age (IQR) — years 30 (15-3…”
BNT162b2 and mRNA-1273 COVID-19 vaccine effectiveness against the SARS-CoV-2 Delta variant in Qatar
Tang, P., Hasan, M. R., Chemaitelly, H., Yassine, H. M., Benslimane, F. M., Al Khatib, H. A., AlMukdad, S., Coyle, P., Ayoub, H. H., Al Kanaani, Z., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01583-4 · Cited by 450 · see citing works
mRNA-1273 COVID-19 vaccine effectiveness against the B.1.1.7 and B.1.351 variants and severe COVID-19 disease in Qatar
Chemaitelly, H., Yassine, H. M., Benslimane, F. M., Al Khatib, H. A., Tang, P., Hasan, M. R., Malek, J. A., Coyle, P., Ayoub, H. H., Al Kanaani, Z., et al. (2021) · Nature Medicine · doi:10.1038/s41591-021-01446-y · Cited by 386 · see citing works
Protection against the Omicron Variant from Previous SARS-CoV-2 Infection
Altarawneh, H. N., Chemaitelly, H., Hasan, M. R., Ayoub, H. H., Qassim, S., AlMukdad, S., Coyle, P., Yassine, H. M., Al-Khatib, H. A., Benslimane, F. M., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmc2200133 · Cited by 445 · see citing works
Duration of mRNA vaccine protection against SARS-CoV-2 Omicron BA.1 and BA.2 subvariants in Qatar
Chemaitelly, H., Ayoub, H. H., AlMukdad, S., Coyle, P., Tang, P., Yassine, H. M., Al-Khatib, H. A., Smatti, M. K., Hasan, M. R., Al-Kanaani, Z., et al. (2022) · Nature Communications · doi:10.1038/s41467-022-30895-3 · Cited by 228 · see citing works
“However, the cohort study design applied earlier to the same population of Qatar yielded ﬁ ndings similar to those of the test-negative case – control design 36,38,39 , supporting the validity of this standard approach in assessing vaccine effectiveness 11,12,36,40 .”
Influential
Effectiveness of CoronaVac among healthcare workers in the setting of high SARS-CoV-2 Gamma variant transmission in Manaus, Brazil: A test-negative case-control study
Hitchings, M. D. T., Ranzani, O., Torres, M. S. S., de Oliveira, S. B., Almirón, M., Said, R., Borg, R., Schulz, W. L., de Oliveira, R. D., da Silva, P. V., et al. (2021) · The Lancet Regional Health - Americas · doi:10.1016/j.lana.2021.100025 · Cited by 200 · see citing works
The Use of Test-negative Controls to Monitor Vaccine Effectiveness
Chua, H., Feng, S., Lewnard, J. A., Sullivan, S. G., Blyth, C. C., Lipsitch, M., & Cowling, B. J. (2019) · Epidemiology · doi:10.1097/ede.0000000000001116 · Cited by 165 · see citing works
Protective Effect of Previous SARS-CoV-2 Infection against Omicron BA.4 and BA.5 Subvariants
Altarawneh, H. N., Chemaitelly, H. S., Ayoub, H. H., Hasan, M. R., Coyle, P. V., Yassine, H. M., Al-Khatib, H. A., Smatti, M. K., Kanaani, Z. A., Al‐Kuwari, E., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmc2209306 · Cited by 144 · see citing works
Associations of BMI with COVID-19 vaccine uptake, vaccine effectiveness, and risk of severe COVID-19 outcomes after vaccination in England: a population-based cohort study
Piernas, C., Patone, M., Astbury, N. M., Gao, M., Sheikh, A., Khunti, K. K., Shankar‐Hari, M., Dixon, S., Coupland, C. A. C., Aveyard, P. N., et al. (2022) · The Lancet Diabetes & Endocrinology · doi:10.1016/s2213-8587(22)00158-9 · Cited by 103 · see citing works
“25,26 However, data on negative test results were not available in the QResearch database we used.”
Effectiveness of seasonal malaria chemoprevention (SMC) treatments when SMC is implemented at scale: Case–control studies in 5 countries
Cairns, M. E., Ceesay, S. J., Sagara, I., Zongo, I., Kessely, H., Gamougam, K., Diallo, A., Ogboi, J. S., Moroso, D., Hulle, S. V., et al. (2021) · PLoS Medicine · doi:10.1371/journal.pmed.1003727 · Cited by 92 · see citing works
“Case–control studies have been widely used to evaluate preventive interventions such as vaccines [10], and other preventive interventions for malaria [12].”
Background
Challenges in estimating influenza vaccine effectiveness
Ainslie, K. E. C., Haber, M., & Orenstein, W. (2019) · Expert Review of Vaccines · doi:10.1080/14760584.2019.1622419 · Cited by 70 · see citing works
“To minimize bias and confounding, it is recommended that case-control studies be carefully designed and implemented, including using specific endpoints, starting the study soon after vaccine introduction, selecting the control population carefully, and matching cases and controls only on key covariates thought to be a…”
Method
Differential protection against SARS-CoV-2 reinfection pre- and post-Omicron
Chemaitelly, H. S., Ayoub, H. H., Coyle, P. V., Tang, P., Hasan, M. R., Yassine, H. M., Thani, A. A. A., Kanaani, Z. A., Al‐Kuwari, E., Jeremijenko, A. M., et al. (2025) · Nature · doi:10.1038/s41586-024-08511-9 · Cited by 59 · see citing works
“The effectiveness of natural infection against reinfection was estimated using the test-negative, case-control study design, which compares the odds of previous infection among SARS-CoV-2-positive tests (cases) to that among SARS-CoV-2-negative tests (controls) 11,12,15,16,63,64 .”
Effects of previous infection, vaccination, and hybrid immunity against symptomatic Alpha, Beta, and Delta SARS-CoV-2 infections: an observational study
Altarawneh, H. N., Chemaitelly, H. S., Ayoub, H. H., Tang, P., Hasan, M. R., Yassine, H. M., Al-Khatib, H. A., Thani, A. A. A., Coyle, P. V., Kanaani, Z. A., et al. (2023) · EBioMedicine · doi:10.1016/j.ebiom.2023.104734 · Cited by 55 · see citing works
Effectiveness of Monovalent Rotavirus Vaccine Against Hospitalization With Acute Rotavirus Gastroenteritis in Kenyan Children
Khagayi, S., Omore, R., Otieno, G. P., Ogwel, B., Ochieng, J. B., Juma, J., Apondi, E., Bigogo, G., Onyango, C. O., Ngama, M., et al. (2019) · Clinical Infectious Diseases · doi:10.1093/cid/ciz664 · Cited by 44 · see citing works
“The statistical power of vaccine effectiveness studies can be affected by small numbers and high vaccine coverage [33].”
BackgroundSelf-citation
Rotavirus Epidemiology and Monovalent Rotavirus Vaccine Effectiveness in Australia: 2010–2017
Maguire, J., Glasgow, K. M., Glass, K., Roczo‐Farkas, S., Bines, J. E., Sheppeard, V. K., Macartney, K. K., & Quinn, H. (2019) · PEDIATRICS · doi:10.1542/peds.2019-1024 · Cited by 43 · see citing works
Effectiveness of influenza vaccination against SARS-CoV-2 infection among healthcare workers in Qatar
Tayar, E., Abdeen, S., Alah, M. A., Chemaitelly, H. S., Bougmiza, I. M., Ayoub, H. H., Kaleeckal, A. H., Latif, A. N., Shaik, R. M., Al‐Romaihi, H. E., et al. (2022) · Journal of Infection and Public Health · doi:10.1016/j.jiph.2022.12.016 · Cited by 44 · see citing works
“The resulting estimates for the adjusted odds ratio and 95% confidence interval (CI) were then used to estimate influenza vaccination effectiveness and corresponding 95% CI using the equation [25,26]:”
Estimating protection afforded by prior infection in preventing reinfection: applying the test-negative study design
Ayoub, H. H., Tomy, M., Chemaitelly, H. S., Altarawneh, H. N., Coyle, P. V., Tang, P., Hasan, M. R., Kanaani, Z. A., Al‐Kuwari, E., Butt, A. A., et al. (2023) · American Journal of Epidemiology · doi:10.1093/aje/kwad239 · Cited by 40 · see citing works
“…already a volume of literature investigating other forms of bias for the test-negative design in the context of vaccine effectiveness estimation, 15,16,27-32 some of which may also apply in the context of PE S estimation, such as for issues relating to testing and applicability of this design for…”
Background
Effectiveness of 1, 2, and 3 Doses of Human Papillomavirus Vaccine Against High-Grade Cervical Lesions Positive for Human Papillomavirus 16 or 18
Jones, M. L. J., Gargano, J. W., Powell, M., Park, I. U., Niccolai, L. M., Bennett, N. M., Griffin, M. R., Querec, T. D., Unger, E. R., Markowitz, L. E., et al. (2019) · American Journal of Epidemiology · doi:10.1093/aje/kwz253 · Cited by 41 · see citing works
Effectiveness of 13-valent pneumococcal conjugate vaccine for prevention of invasive pneumococcal disease among children in the United States between 2010 and 2019: An indirect cohort study
Andrejko, K. L., Gierke, R., Rowlands, J. V., Rosen, J. B., Thomas, A. R., Landis, Z., Rosales, M., Petit, S., Schaffner, W., Holtzman, C., et al. (2024) · Vaccine · doi:10.1016/j.vaccine.2024.04.061 · Cited by 38 · see citing works
“The indirect cohort method mitigates potential selection biases that may arise due to differences in the characteristics between cases and controls as both are identified using the same case definition [15,35].”
MethodSelf-citation
Duration of protection of BNT162b2 and mRNA-1273 COVID-19 vaccines against symptomatic SARS-CoV-2 Omicron infection in Qatar
Chemaitelly, H., Ayoub, H. H., AlMukdad, S., Tang, P., Hasan, M. R., Yassine, H. M., Khatib, H. A. A., Smatti, M. K., Coyle, P., Kanaani, Z. A., et al. (2022) · doi:10.1101/2022.02.07.22270568 · Cited by 30 · see citing works
Tick-borne encephalitis vaccine effectiveness and barriers to vaccination in Germany
Nygren, T. M., Pilic, A., Böhmer, M. M., Wagner-Wiening, C., Wichmann, O., Harder, T., & Hellenbrand, W. (2022) · Scientific Reports · doi:10.1038/s41598-022-15447-5 · Cited by 37 · see citing works
Choices in vaccine trial design in epidemics of emerging infections
Kahn, R. J., Rid, A., Smith, P. G., Eyal, N., & Lipsitch, M. (2018) · PLoS Medicine · doi:10.1371/journal.pmed.1002632 · Cited by 36 · see citing works
Self-citation
Pertussis in the Association of Southeast Asian Nations: epidemiology and challenges
Thisyakorn, U., Tantawichien, T., Thisyakorn, C., & Buchy, P. (2019) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2019.07.016 · Cited by 36 · see citing works
Population immunity of natural infection, primary-series vaccination, and booster vaccination in Qatar during the COVID-19 pandemic: an observational study
Qassim, S. H., Chemaitelly, H. S., Ayoub, H. H., Coyle, P. V., Tang, P., Yassine, H. M., Thani, A. A. A., Al-Khatib, H. A., Hasan, M. R., Kanaani, Z. A., et al. (2023) · EClinicalMedicine · doi:10.1016/j.eclinm.2023.102102 · Cited by 32 · see citing works
Vitamin D deficiency in pregnancy and the risk of preterm birth: a nested case–control study
Tahsin, T., Khanam, R., Chowdhury, N. H., Hasan, A. S. M. T., Hosen, M. B., Rahman, S., Roy, A. K., Ahmed, S., Raqib, R., & Baqui, A. H. (2023) · BMC Pregnancy and Childbirth · doi:10.1186/s12884-023-05636-z · Cited by 33 · see citing works
Self-citation
Long term effectiveness of inactivated vaccine BBIBP-CorV (Vero Cells) against COVID-19 associated severe and critical hospitalization in Morocco
Belayachi, J., Obtel, M., Mhayi, A., Razıne, R., & Abouqal, R. (2022) · PLoS ONE · doi:10.1371/journal.pone.0278546 · Cited by 33 · see citing works
“The testnegative design has been used extensively to estimate VE among medically attended influenza virus illness and is believed to minimize biases associated with access to vaccines and healthcare-seeking behaviors, and recommended by the WHO interim guidance [22,23].”
Method
PCV13 Vaccination of Adults against Pneumococcal Disease: What We Have Learned from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA)
Theilacker, C., Fletcher, M. A., Jódar, L., & Gessner, B. D. (2022) · Microorganisms · doi:10.3390/microorganisms10010127 · Cited by 31 · see citing works
“impact evaluations of PCV13 adult vaccination on IPD or CAP are more challenging to interpret, as vaccine impact measured by surveillance systems is a combination of disease reduction in directly vaccinated individuals and disease reduction among unvaccinated persons due to less carriage among and transmission from va…”
Background
Protocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo
Watson‐Jones, D., Kavunga‐Membo, H., Grais, R. F., Ahuka, S. M., Roberts, N., Edmunds, W. J., Choi, E. M.-L., Roberts, C. H., Edwards, T., Camacho, A., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2021-055596 · Cited by 29 · see citing works
Estimating protection afforded by prior infection in preventing reinfection: Applying the test-negative study design
Ayoub, H. H., Tomy, M., Chemaitelly, H., Altarawneh, H. N., Coyle, P., Tang, P., Hasan, M. R., Kanaani, Z. A., Kuwari, E. A., Butt, A. A., et al. (2022) · doi:10.1101/2022.01.02.22268622 · Cited by 41 · see citing works
Effectiveness of typhoid conjugate vaccine against culture-confirmed typhoid in a peri-urban setting in Karachi: A case-control study
Batool, R., Yousafzai, M. T., Qureshi, S., Ali, M., Sadaf, T., Mehmood, J., Ashorn, P., & Qamar, F. N. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.08.051 · Cited by 28 · see citing works
Real world effectiveness of covid-19 vaccines
Hungerford, D., & Cunliffe, N. A. (2021) · BMJ · doi:10.1136/bmj.n2034 · Cited by 26 · see citing works
Clinical Research: A Review of Study Designs, Hypotheses, Errors, Sampling Types, Ethics, and Informed Consent
singh, A. P., Vadakedath, S., & Kandi, V. (2023) · Cureus · doi:10.7759/cureus.33374 · Cited by 25 · see citing works
“Such studies are frequently used to assess the efficacy of vaccines among the population [17].”
Background
Breed susceptibility for common surgically treated orthopaedic diseases in 12 dog breeds
Boge, G. S., Moldal, E. R., Dimopoulou, M., Skjerve, E., & Bergström, A. (2019) · Acta veterinaria Scandinavica · doi:10.1186/s13028-019-0454-4 · Cited by 24 · see citing works
Protection of natural infection against reinfection with SARS-CoV-2 JN.1 variant
Chemaitelly, H. S., Coyle, P. V., Kacem, M. A. B. H., Ayoub, H. H., Tang, P., Hasan, M. R., Yassine, H. M., Thani, A. A. A., Kanaani, Z. A., Al‐Kuwari, E., et al. (2024) · Journal of Travel Medicine · doi:10.1093/jtm/taae053 · Cited by 21 · see citing works
Effectiveness of COVID-19 vaccines on hospitalization and death in Guilan, Iran: a test-negative case-control study
Heidarzadeh, A., Moridani, M. A., Khoshmanesh, S., Kazemi, S., Hajiaghabozorgi, M., & Karami, M. (2022) · International Journal of Infectious Diseases · doi:10.1016/j.ijid.2022.12.024 · Cited by 20 · see citing works
Effectiveness of two doses of Euvichol-plus oral cholera vaccine in response to the 2017/2018 outbreak: a matched case–control study in Lusaka, Zambia
Sialubanje, C., Kapina, M., Chewe, O., Matapo, B. B., Moraes, A. N., Gianetti, B., Ngosa, W., Kasonde, M., Musonda, K. G., Mulenga, M., et al. (2022) · BMJ Open · doi:10.1136/bmjopen-2022-066945 · Cited by 19 · see citing works
Typhoid conjugate vaccine effectiveness in Malawi: evaluation of a test-negative design using randomised, controlled clinical trial data
Liang, Y., Driscoll, A. J., Patel, P. D., Datta, S., Voysey, M., French, N., Jamka, L. P., Henrion, M., Ndeketa, L., Laurens, M. B., et al. (2022) · The Lancet Global Health · doi:10.1016/s2214-109x(22)00466-1 · Cited by 19 · see citing works
Effectiveness of a single-dose mass dengue vaccination in Cebu, Philippines: A case-control study
Ylade, M. C., Agrupis, K. A., Daag, J. V., Crisostomo, M. V., Tabuco, M. O., Sy, A. K., Nealon, J., Macina, D., Sarol, J. N., Jr., Deen, J. L., et al. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.07.042 · Cited by 18 · see citing works
Effectiveness of mRNA boosters after homologous primary series with BNT162b2 or ChAdOx1 against symptomatic infection and severe COVID-19 in Brazil and Scotland: A test-negative design case–control study
Silva, T. C., Shah, S. A., Robertson, C., Sanchez, M. N., Katikireddi, S. V., Oliveira, V. D. A., Paixão, E. S., Rudan, I., Bertoldo, J., Penna, G. O., et al. (2023) · PLoS Medicine · doi:10.1371/journal.pmed.1004156 · Cited by 17 · see citing works
Effectiveness of two and three doses of COVID-19 mRNA vaccines against infection, symptoms, and severity in the pre-omicron era: A time-dependent gradient
Sukik, L., Chemaitelly, H. S., Ayoub, H. H., Coyle, P. V., Tang, P., Yassine, H. M., Thani, A. A. A., Hasan, M. R., Kanaani, Z. A., Al‐Kuwari, E., et al. (2024) · Vaccine · doi:10.1016/j.vaccine.2024.04.026 · Cited by 17 · see citing works
Effectiveness of the 10-valent pneumococcal conjugate vaccine against radiographic pneumonia among children in rural Bangladesh: A case-control study
McCollum, E. D., Ahmed, S., Roy, A., Chowdhury, N. H., Schuh, H. B., Rizvi, S. J. R., Hanif, A. A. M., Khan, A. M., Mahmud, A., Pervaiz, F., et al. (2020) · Vaccine · doi:10.1016/j.vaccine.2020.08.035 · Cited by 16 · see citing works
Self-citation
Field evaluation of typhoid conjugate vaccine in a catch-up campaign among children aged 9 months to 15 years in Sindh, Pakistan
Thobani, R., Yousafzai, M. T., Sultana, S., Kazi, A. M., Jan, M., Rafey, A., Khan, A., Irfan, S., Ujjan, I. U., Brown, N., et al. (2022) · Vaccine · doi:10.1016/j.vaccine.2022.06.072 · Cited by 15 · see citing works
The effectiveness of the 13-valent pneumococcal conjugate vaccine against hypoxic pneumonia in children in Lao People's Democratic Republic: An observational hospital-based test-negative study
Weaver, R., Nguyen, C. D., Chan, J., Vilivong, K., Lai, J., Lim, R., Satzke, C., Vongsakid, M., Newton, P. N., Mulholland, K., et al. (2020) · The Lancet Regional Health - Western Pacific · doi:10.1016/j.lanwpc.2020.100014 · Cited by 15 · see citing works
“Measuring VE using the tandard case-control design is challenging due to difficulties in electing controls that are representative of the source populaion of the cases [13] .”
BackgroundMethodInfluentialSelf-citation
An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia—Study Protocol
Marshall, H. S., Andraweera, P. H., Ward, J. S., Kaldor, J. M., Andrews, R. M., Macartney, K. K., Richmond, P., Krause, V., Koehler, A. P., Whiley, D. M., et al. (2022) · Vaccines · doi:10.3390/vaccines10020309 · Cited by 15 · see citing works
“Although increasing the number of controls per case increases statistical power, beyond a ratio of four controls per case only small improvements in power are expected [24,25].”
Background
Impact of the Rotavirus Vaccination Program in Norway After Four Years With High Coverage
Bruun, T., Salamanca, B. V., Bekkevold, T., Døllner, H., Gibory, M., Gilje, A. M., Haarr, E., Kran, A. B., Leegaard, T. M., Nakstad, B., et al. (2020) · The Pediatric Infectious Disease Journal · doi:10.1097/inf.0000000000003020 · Cited by 14 · see citing works
“Case-control studies are more efficient to assess VE in settings with vaccine coverage under 80%, and there is a stronger potential for confounding if the coverage is very high or low.(52) Thus, our study was underpowered to estimate VE by genotypes, age groups or number of doses.”
Background
Does Training Innate Immunity Confer Broad-spectrum Protection Against Bone and Joint Infection in a Mouse Model?
Zhu, H., Lin, J., Wei, H., Bao, B., Gao, T., & Zheng, X. (2020) · Clinical Orthopaedics and Related Research · doi:10.1097/corr.0000000000001461 · Cited by 14 · see citing works
“For certain pathogens, the most economical and reliable strategy for infection prevention is enhancing patients’ immune defense by using vaccines [22].”
Background
Vaccine effectiveness against severe COVID-19 during the Omicron wave in Germany: results from the COViK study
(2023) · doi:10.1007/s15010-023-02012-z · Cited by 13 · see citing works
Long term effectiveness of inactivated vaccine BBIBP-CorV (Vero Cells) against COVID-19 associated severe and critical hospitalization in MoroccoPreprint
Belayachi, J., Obtel, M., Razıne, R., & Abouqal, R. (2022) · medRxiv · doi:10.1101/2022.01.25.22269822 · Cited by 13 · see citing works
Examining Duration of Protection: Should a Booster Dose Be Part of All Infant Pneumococcal Conjugate Vaccine Programs?
Whitney, C. G. (2018) · Clinical Infectious Diseases · doi:10.1093/cid/ciy135 · Cited by 12 · see citing works
Self-citation
Effectiveness of vaccines in preventing hospitalization due to COVID-19: A multicenter hospital-based case-control study, Germany, June 2021 to January 2022
(2022) · doi:10.1016/j.vaccine.2022.11.065 · Cited by 10 · see citing works
Impact of CoronaVac on Covid-19 outcomes of elderly adults in a large and socially unequal Brazilian city: A target trial emulation study
Monteiro, H. S., Neto, A. S. L., Kahn, R. J., de Sousa, G. D. S., Carmona, H. A., Andrade, J. S., & Castro, M. C. (2023) · Vaccine · doi:10.1016/j.vaccine.2023.07.065 · Cited by 9 · see citing works
Real-world vaccine effectiveness of typhoid conjugate vaccine in children and adolescents: a systematic review and meta-analysis
Haposan, J. H., Icanervilia, A. V., Watts, E., Widyaningsih, S. A., Ulfa, S., Widayanti, P., Laksanawati, I. S., Thobari, J. A., & Bines, J. E. (2025) · Vaccine · doi:10.1016/j.vaccine.2025.127872 · Cited by 9 · see citing works
Investigating Factors Associated with Vaccine Hesitancy in Makkah, KSA
Albarakati, R., Almatrafi, L., Fatta, G., Fatani, B., & Alhindi, Y. Z. (2019) · World Journal of Vaccines · doi:10.4236/wjv.2019.92003 · Cited by 9 · see citing works
“Immune cells are also called lymphocytes and mainly consist of B-lymphocytes, T-lymphocytes and macrophages [4].”
Background
Effectiveness of Rotarix® vaccine in Africa in the first decade of progressive introduction, 2009-2019: systematic review and meta-analysis
Murunga, N., Otieno, G. P., Maia, M. F., & Agoti, C. N. (2020) · Wellcome Open Research · doi:10.12688/wellcomeopenres.16174.2 · Cited by 9 · see citing works
Feasibility of case-control and test-negative designs to evaluate dengue vaccine effectiveness in Malaysia
Nealon, J., Lim, W. Y., Moureau, A., Linus-Lojikip, S., Junus, S., Kumar, S. S., Nachiappan, J. P., Sekaran, S. D., Radigue, C., Cowling, B. J., et al. (2019) · Vaccine · doi:10.1016/j.vaccine.2019.07.083 · Cited by 8 · see citing works
Folate deficiency in pregnancy and the risk of preterm birth: A nested case-control study
Lazar, V. M. A., Rahman, S., Chowdhury, N. H., Hasan, T., Akter, S., Islam, M. S., Ahmed, S., Baqui, A. H., & Khanam, R. (2024) · Journal of Global Health · doi:10.7189/jogh.14.04120 · Cited by 7 · see citing works
“Since it uses a case-control design, it may be susceptible to confounding and selection bias [47].”
BackgroundSelf-citation
Influenza Vaccine Effectiveness against Influenza A-Associated Outpatient and Emergency-Department-Attended Influenza-like Illness during the Delayed 2022–2023 Season in Beijing, China
Zhang, L., Lu, G., Ma, C., Zhang, J., Li, J., Duan, W., Ma, J., Shi, W., Wang, Y., Sun, Y., et al. (2024) · Vaccines · doi:10.3390/vaccines12101124 · Cited by 7 · see citing works
“It was indicated that results of VE estimation are most likely to be certain when the vaccine coverage is between 20 and 80% [33].”
Background
Effectiveness of a hepatitis E vaccine against medically-attended symptomatic infection in HBsAg-positive adults from a test-negative design study
Zhuang, C., Liu, X., Huang, X., Lu, J., Zhu, K., Liao, M., Chen, L., Jiang, H.-M., Zang, X., Wang, Y., et al. (2025) · Nature Communications · doi:10.1038/s41467-025-57021-3 · Cited by 7 · see citing works
“Last, it is generally recognized that case-control studies achieve optimal power when vaccination coverage ranges between 20% and 80% 41 .”
Estimating the impact of pneumococcal conjugate vaccines on childhood pneumonia in sub-Saharan Africa: A systematic review
Onwuchekwa, C., Edem, B. E., Williams, V., & Oga, E. A. (2020) · F1000Research · doi:10.12688/f1000research.25227.1 · Cited by 7 · see citing works
Towards quality improvement of vaccine concept mappings in the OMOP vocabulary with a semi-automated method
Abeysinghe, R., Black, A., Kaduk, D., Li, Y., Reich, C., Davydov, A., Yao, L., & Cui, L. (2022) · Journal of Biomedical Informatics · doi:10.1016/j.jbi.2022.104162 · Cited by 6 · see citing works
“Real-world data (RWD) is critical to evaluate the safety, effectiveness, and uptake of vaccines [1].”
Background
The added effect of non-pharmaceutical interventions and lifestyle behaviors on vaccine effectiveness against severe COVID-19 in Chile: A matched case-double control study
Urquidi, C., Santelices, E., Lagomarcino, A. J., Valenzuela, M. T., Larrañaga, N., Gonzalez, E., Axel Pavez, R., Wosiack, A., Maturana, M., Moller, P., et al. (2023) · Vaccine · doi:10.1016/j.vaccine.2023.03.060 · Cited by 5 · see citing works
“Stringent matching by the neighborhood of residence for community controls, allowed our study to comply with the assumption of a similar selection of cases and controls, controlling for the influence of socio-environmental factors [32].”
Background
Measuring indirect transmission-reducing effects in tuberculosis vaccine efficacy trials: why and how?
Nelson, K., Churchyard, G., Cobelens, F. G. J., Hanekom, W. A., Hill, P. C., Lopman, B. A., Mave, V., Rangaka, M. X., Vekemans, J., White, R. G., et al. (2023) · The Lancet Microbe · doi:10.1016/s2666-5247(23)00112-x · Cited by 4 · see citing works
A framework for monitoring RSV prevention product effectiveness in the United States
Roper, L. E., Link‐Gelles, R., Surie, D., DeCuir, J., Zambrano, L. D., Prill, M. M., Havers, F. P., Jones, J. M., Melgar, M., Hall, A. J., et al. (2025) · Vaccine · doi:10.1016/j.vaccine.2024.126633 · Cited by 5 · see citing works
Evaluation strategies for measuring pneumococcal conjugate vaccine impact in low-resource settings
von Mollendorf, C., Lim, R., Choummanivong, M., Sychareun, V., Vilivong, K., Lai, J., Chan, J., Dunne, E. M., Phommachanh, S., Moore, K. A., et al. (2021) · Expert Review of Vaccines · doi:10.1080/14760584.2021.1965474 · Cited by 5 · see citing works
“There are however a number of challenges and limitations when conducting these types of studies [27,28].”
BackgroundSelf-citation
Effectiveness of the combined MMRV Priorix-Tetra™ vaccine against varicella in a large Italian region: A case-control study
Fortunato, F., Musco, A., Iannelli, G., Meola, M., Lopalco, P. L., & Martinelli, D. (2024) · Vaccine · doi:10.1016/j.vaccine.2024.02.002 · Cited by 4 · see citing works
SARS-CoV-2 Vaccine Effectiveness in Hospitalized Patients: A Multicenter Test-Negative Case–Control Study
Thirión-Romero, I. I., Plata, R. F., Pérez-Kawabe, M., Meza-Meneses, P. A., Castro-Fuentes, C. A., Rivera-Martínez, N. E., Barrón-Palma, E. V., Sánchez-Sandoval, A. L., Cornejo‐Juárez, P., Sepúlveda-Delgado, J., et al. (2023) · Vaccines · doi:10.3390/vaccines11121779 · Cited by 4 · see citing works
“…revealed two essential ﬁndings: ) vaccine effectiveness, when adjusted for covariates, to prevent hospitalization was % with at least one COVID-19 vaccine and 73% for a complete vaccination scheme in COVID-19 outbreak dominated by the Delta variant; (2) the analysis by vaccine type In several…”
Background
A Review of Vaccine Efficacy Measures
Dasgupta, S. (2019) · Vaccination Research – Open Journal · doi:10.17140/vroj-4-110 · Cited by 4 · see citing works
Effects of previous infection, vaccination, and hybrid immunity against symptomatic Alpha, Beta, and Delta infectionsPreprint
Altarawneh, H. N., Chemaitelly, H. S., Ayoub, H. H., Tang, P., Hasan, M. R., Yassine, H. M., Al-Khatib, H. A., Thani, A. A. A., Coyle, P. V., Kanaani, Z. A., et al. (2023) · medRxiv · doi:10.1101/2023.04.21.23288917 · Cited by 4 · see citing works
Effectiveness of Rotarix® vaccine in Africa in the first decade of progressive introduction, 2009-2019: systematic review and meta-analysis
Murunga, N., Otieno, G. P., Maia, M. F., & Agoti, C. N. (2020) · Wellcome Open Research · doi:10.12688/wellcomeopenres.16174.1 · Cited by 3 · see citing works
Hib combination vaccines: efficient and effective
Cohen, C., & von Gottberg, A. (2018) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(18)30234-2 · Cited by 3 · see citing works
Self-citation
Pfizer-BioNTech mRNA Vaccine Protection among Children and Adolescents Aged 12–17 Years against COVID-19 Infection in Qatar
Osman, K., Mundodan, J. M., Chowdhury, J., Ravi, R. P., Baaboura, R., Albuquerque, J., Riaz, B., Emran, R. Y., Batoul, K., Esameldin, A. M., et al. (2023) · Vaccines · doi:10.3390/vaccines11101522 · Cited by 2 · see citing works
“The effectiveness against Alpha and Beta variants was high: over 75% in Qatar [8,28–30].”
Background
Comparative effectiveness of one versus two doses of COVID-19 vaccines in Qatar: Evidence of converging protection over time
Chemaitelly, H. S., Ayoub, H. H., Coyle, P. V., Tang, P., Hasan, M. R., Yassine, H. M., Thani, A. A. A., Kanaani, Z. A., Al‐Kuwari, E., Jeremijenko, A. M., et al. (2025) · Vaccine · doi:10.1016/j.vaccine.2025.127556 · Cited by 2 · see citing works
Effectiveness of ChAdOx1 nCoV-19 (Vaxzevria) primary series vaccine against SARS-CoV-2 beta and delta variants: a nationwide study
Chemaitelly, H. S., Ayoub, H. H., Coyle, P. V., Tang, P., Hasan, M. R., Yassine, H. M., Thani, A. A. A., Kanaani, Z. A., Al‐Kuwari, E., Jeremijenko, A. M., et al. (2025) · BMC Infectious Diseases · doi:10.1186/s12879-025-11410-7 · Cited by 2 · see citing works
Identifying and reducing risks of neurological complications associated with vaccination
Handunnetthi, L., Ramasamy, M., Turtle, L. C. W., & Hunt, D. P. J. (2024) · Nature Reviews Neurology · doi:10.1038/s41582-024-01000-7 · Cited by 3 · see citing works
“Case–control studies, by contrast, compare past exposure with vaccination between individuals who have and have not experienced the adverse event of interest 21 (termed ‘cases’ and ‘controls’, respectively).”
Upper and Lower Endoscopic Findings in Mesenteric Panniculitis Patients: A Case-Control Study
Schweistein, H., Weintraub, Y., Hornik‐Lurie, T., Haskiya, H., Rave, A., Bendersky, A. G., Issa, N., Naftali, T., & Gingold‐Belfer, R. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13226709 · Cited by 2 · see citing works
Designing effectiveness and impact studies for respiratory syncytial virus immunisation in low- and middle-income countries
Reyburn, R., Russell, F. M., Munywoki, P. K., Franzel, L., Huong, T. T. G., Feikin, D. R., & Bont, L. (2025) · Vaccine · doi:10.1016/j.vaccine.2025.127397 · Cited by 2 · see citing works
Self-citation
Estimation of oral poliovirus vaccine effectiveness in Afghanistan, 2010–2020
Chard, A. N., Martinez, M., Matanock, A. M., & Kassem, A. M. (2021) · Vaccine · doi:10.1016/j.vaccine.2021.09.020 · Cited by 2 · see citing works
Reduction in COVID-19 Vaccine Effectiveness against SARS-CoV-2 Variants in Seoul according to Age, Sex, and Symptoms: A Test-Negative Case-Control Study
Gim, H., Oh, S.-Y., Lee, H., Lee, S., Seo, H., Park, Y., & Park, J. (2022) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph192416958 · Cited by 2 · see citing works
“VE was calculated as (1 − OR) × 100 (%) [33,34].”
Protection conferred by SARS-CoV-2 infection across a spectrum of reinfection symptoms and severities
Sukik, L., Chemaitelly, H. S., Ayoub, H. H., Coyle, P. V., Tang, P., Hasan, M. R., Yassine, H. M., Thani, A. A. A., Kanaani, Z. A., Al‐Kuwari, E., et al. (2025) · BMJ Open Respiratory Research · doi:10.1136/bmjresp-2024-002718 · Cited by 1 · see citing works
“38 39 This extended design leverages the widespread testing conducted during the COVID-19 pandemic, where individuals were tested for various reasons, such as routine requirements, and has been thoroughly investigated and validated through numerous studies, sensitivity analyses, negative control…”
Apoyo político y microplanificación como factores de éxito para una campaña de vacunación de seguimiento de alta calidad, Ecuador, 2023
Aguinaga-Romero, G., Jacome, C., Márquez, J., Pinos, J., Carmenates, A., Simancas‐Racines, D., Parise-Vasco, J. M., Viteri-García, A. A., Withembury, Á., Anchayhua, Y., et al. (2025) · Revista Panamericana de Salud Pública · doi:10.26633/rpsp.2025.32 · Cited by 1 · see citing works
Effectiveness of the 13-valent pneumococcal conjugate vaccine against medically attended pneumococcal lower respiratory tract infection among older adults: a case–control study
Ngamprasertchai, T., Phatharodom, P., Intalapaporn, K., Sutthipool, K., Chongtrakool, P., Yungyuen, T., Luvira, V., Ratanasuwan, W., Rattanaumpawan, P., Lawpoolsri, S., et al. (2025) · Scientific Reports · doi:10.1038/s41598-025-24784-0 · Cited by 1 · see citing works
A comparison of the test-negative and the matched case-control study designs for estimation of EV71 vaccine immunological surrogate endpoints from a randomized controlled trial
Zhang, L., Jin, P., Wei, M., Jiang, H.-D., Li, J., & Zhu, F. (2022) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2022.2073751 · Cited by 1 · see citing works
Vaccination Can Prevent Severe Pulmonary Disease in COVID-19 Positive Patients: A Case-Control Study
Ravichandran, S., Vijayakumar, K., Vishwajit, G. V., & Siva, P. M. (2023) · Cureus · doi:10.7759/cureus.45638 · Cited by 1 · see citing works
“Case-control studies are generally used to assess the effectiveness of vaccines after their implementation in public health programs by using endpoints of diseases like lung involvement [9].”
Background
Evaluation of enterovirus A71 vaccine effectiveness against pediatric hand, foot, and mouth disease caused by enterovirus A71 virus in Tianjin, China, 2016–2023: A test-negative design case-control study
Gao, L., Cheng, S., & Li, L. (2025) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2025.2572181 · Cited by 1 · see citing works
Viral Vectors in Veterinary Vaccine Development
Kumar, A., Pandita, P., Modi, H., Alom, S., & Chavda, V. P. (2025) · Wiley eBooks · doi:10.1002/9781394271566.ch9 · Cited by 1 · see citing works
Kinematic cervical rotation performance in patients with acute non-specific neck pain during the DidRen test improves after manual mobilizations regardless of the painful spinal levelPreprint
Hage, R., Detrembleur, C., Dierick, F., Brismée, J., Roussel, N. A., & Pitance, L. (2021) · Research Square · doi:10.21203/rs.3.rs-403229/v1
Real life vaccine effectiveness against COVID-19: Proof of the pudding!
Datta, R. (2021) · Medical Journal Armed Forces India · doi:10.1016/j.mjafi.2021.07.008
“Both types of study calculate the risk of infection and disease among vaccinated and unvaccinated persons, and determine the reduction in risk.(4) While vaccine efficacy is studied in an ideal setting, as a prospective randomized control trial (where effect of vaccination in prevention of infection or disease can be p…”
Background
Effectiveness of COVID-19 Vaccine in Prevention of Mortality Among Moderate-Severe Cases
Yadav, A. K., Vasisht, K., Ghosh, S., & Bobdey, S. (2022) · Medical Journal of Dr D Y Patil Vidyapeeth · doi:10.4103/mjdrdypu.mjdrdypu_195_22
The Effectiveness of Covid-19 Vaccination in Indonesian Population: A Case-Control Study Protocol
Idaiani, S., Nurhayati, N., Delima, D., Hendarwan, H., Widowati, L., Tarigan, I. U., Afriansyah, N., Wirasmi, S., Yunitawati, D., Adiningsih, S., et al. (2023) · doi:10.2991/978-94-6463-112-8_71
Evaluasi Implementasi Epidemiologi Sistem Surveilans Program Kesehatan Ibu dan Anak (KIA) Kabupaten Pangkep
Hasanuddin, A., Azizah, F., Setianto, R., Hasin, A., & Hasliani (2023) · Pro Health Jurnal Ilmiah Kesehatan · doi:10.35473/proheallth.v5i1.2074
POST-LICENSURE EFFECTIVENESS OF THE HAEMOPHILUS INFLUENZA TYPE B VACCINE ON COMMUNITY-ACQUIRED PNEUMONIA AMONG CHILDREN: A CASE-CONTROL STUDY IN REPUBLIC OF MOLDOVA
Revenco, N., Balanuta, A.-M., BUJOR, D., Horodisteanu-Banuh, A., Grin, O., Holban, A., & ROTARI, A. (2023) · Archives of the Balkan Medical Union · doi:10.31688/abmu.2023.58.4.11
A Novel Practical Approach for Directly Assessing COVID-19 Vaccine Efficacy against HospitalizationPreprint
Kirsch, S., Marik, P. E., Rogers, C., Cosgrove, K., & Mead, M. N. (2024) · Preprints.org · doi:10.20944/preprints202408.0338.v1
Health Facilities-Based Case-Control Evaluation of the Effectiveness of Malaria Control Interventions
Kesteman, T. (2025) · Springer eBooks · doi:10.1007/978-1-4614-8326-7_148
Effectiveness of 10-valent pneumococcal conjugate vaccine against radiologically confirmed pneumonia and invasive pneumococcal disease among young children in Mozambique
Sigaúque, B., Vilanculos, L., Chaúque, A., Moiane, B., Mucavele, H., Massora, S., Acácio, S., Sacoor, C. N., Quintó, L., Matsinhe, B., et al. (2026) · Vaccine · doi:10.1016/j.vaccine.2026.128237
“…routine infant immunization programs [6] and the most widely used formulations are 10-valent (GlaxoSmithKline, PCV10) and 13-valent 13-valent ( Pfizer, Data on PCV effectiveness against pneumonia using the case-control method, which complements data on vaccine impact [13], are limited [14–17].”
Self-citation
Annual immunogenicity measurements in randomized clinical trials help reveal heterogeneity in long-term vaccine efficacy: a pooled logistic regression modeling study
Dudášová, J., Valenta, Z., Măgălie, A., Nieddu, G. T., & Sachs, J. R. (2026) · Vaccine · doi:10.1016/j.vaccine.2026.128326
Effectiveness of Seasonal Influenza Vaccination Against Medically Attended Influenza in People With Chronic Respiratory Diseases: A Multicenter, Test-Negative, Case-control Study
Luo, Y., Yu, J., Yu, X., Xin, L., Li, Z., Gong, E., Xin, H., Huang, Q., Ye, C., Hao, L., et al. (2025) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofaf684
“%) in the 18–59-year CRD subgroup and limited sample size compared to the other age groups [41].”
Pneumococcal conjugate vaccine effectiveness against hypoxemia in children with suspected pneumonia in Kenya; analysis from a real-world sentinel surveillance platform
Mutisya, F., Agogo, G. O., Opudo, J., Jepkorir, B., Mwatondo, A. J., Langat, D., Munyua, P. M., Chege, D., & Hines, J. Z. (2026) · PLoS ONE · doi:10.1371/journal.pone.0351500
“While VE studies might be best done soon after vaccine introduction when coverage is below 80% [14], providing data from real world conditions on vaccine performance can help provide evidence to sustain vaccination programs.”
Quantitative systems pharmacology of HIV PrEP and PEP
Iannuzzi, S., Zhang, L., Liebenberg, A., Kim, H.-Y., & von Kleist, M. (2026) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2026.2715711
“Similar to assessing vaccine efficacy, prophylactic efficacy may also be confirmed in case-control studies [10].”

Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and control
Verani, J. R., Baqui, A. H., Broome, C. V., Cherian, T., Cohen, C., Farrar, J. L., Feikin, D. R., Groome, M. J., Hajjeh, R. A., & Zaidi, A. K. M. (2017) · eCommons - AKU (Aga Khan University)
Self-citation
Case-control vaccine effectiveness studies: Data collection, analysis and reporting results
Verani, J. R., Baqui, A. H., Broome, C. V., Cherian, T., Cohen, C., Farrar, J. L., Feikin, D. R., Groome, M. J., Hajjeh, R. A., Johnson, H. L., et al. (2017) · Vaccine · doi:10.1016/j.vaccine.2017.04.035 · Cited by 37 · see citing works
Self-citation
Case-Control Studies to Assess the Effectiveness of Vaccines
Shapiro, E. D. (2014) · Journal of the Pediatric Infectious Diseases Society · doi:10.1093/jpids/piu058 · Cited by 4 · see citing works
Evaluating Vaccination Effectiveness and Vaccine Efficacy by means of Case-Control Studies
Comstock, G. W. (1994) · Epidemiologic Reviews · doi:10.1093/oxfordjournals.epirev.a036147 · Cited by 66 · see citing works
Use of the Case-Control Approach in Vaccine Evaluation: Efficacy and Adverse Effects
Rodrigues, L. C., & Smith, P. G. (1999) · Epidemiologic Reviews · doi:10.1093/oxfordjournals.epirev.a017988 · Cited by 76 · see citing works
Self-citation

Authors: Verani, J. R., Baqui, A. H., Broome, C. V., Cherian, T., Cohen, C., Farrar, J. L., Feikin, D. R., Groome, M. J., Hajjeh, R. A., Johnson, H. L., Madhi, S. A., Mulholland, K., O'Brien, K. L., Parashar, U. D., Patel, M. M., Rodrigues, L. C., Santosham, M., Scott, J. A., Smith, P. G., Sommerfelt, H., Tate, J. E., Victor, J. C., Whitney, C. G., Zaidi, A. K., & Zell, E. R.
Affiliations: Centers for Disease Control and Prevention (US)
Johns Hopkins University (US)
Emory University (US)
World Health Organization (CH)
National Institute for Communicable Diseases (ZA)
University of the Witwatersrand (ZA)
Gavi (CH)
Royal Children's Hospital (AU)
London School of Hygiene & Tropical Medicine (GB)
Kenya Medical Research Institute (KE)
Norwegian Institute of Public Health (NO)
Aga Khan University (PK)
Corresponding author: Verani, Jennifer R.
ORCID: Verani, Jennifer R.
Baqui, Abdullah H.
Cherian, Thomas
Cohen, Cheryl
Farrar, Jennifer L.
Feikin, Daniel R.
Groome, Michelle J.
Hajjeh, Rana A.
Johnson, Hope L.
Madhi, Shabir A.
Mulholland, Kim
Parashar, Umesh D.
Patel, Manish M.
Rodrigues, Laura C.
Scott, J. Anthony
Smith, Peter G.
Sommerfelt, Halvor
Tate, Jacqueline E.
Victor, J. Chris
Whitney, Cynthia G.
Venue: Vaccine
Publisher: Elsevier BV
Published: 2017-06
Volume: 35
Issue: 25
Pages: 3295-3302
ISSN: 0264-410X (ISSN-L)
DOI: 10.1016/j.vaccine.2017.04.037
PMC: PMC7007298
OpenAlex: W2605758023
Cited by: 102
References: 82
Citations by year: 2026: 6 · 2025: 14 · 2024: 9 · 2023: 17 · 2022: 22 · 2021: 14 · 2020: 7 · 2019: 10 · 2018: 3
FWCI: 1.02
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Vaccine (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
PubMed Central (acceptedVersion, cc-by-nc-nd)
LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
NORA - Norwegian Open Research Archives (submittedVersion, cc-by-nc-nd)
NORA - Norwegian Open Research Archives (submittedVersion, other-oa)
Minerva Access (University of Melbourne) (submittedVersion, cc-by-nc-nd)
Funders: GAVI Alliance
World Health Organization
Wellcome Trust (098532/B/12/Z, 203077)
Centers for Disease Control and Prevention (U01IP001048)
Medical Research Council (MR/K012126/1)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Social Sciences › Health › Vaccine Coverage and Hesitancy
Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Keywords: vaccine effectiveness, case-control study, research design, confounding, vaccine introduction, health-seeking behavior, vaccination practices
MeSH terms: Immunogenicity, Vaccine, Female, Humans, Male, Vaccination, Vaccines, Case-Control Studies, Treatment Outcome, Immunization Programs, Control Groups

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Case-control vaccine effectiveness studies: Preparation, design, and enrollment of cases and controls

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