The DOI matches its Crossref record; 30 of the 31 references it cites were found in a registry or an index.
A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants
Open accessAbstract
BACKGROUND: The candidate malaria vaccine RTS,S/AS01 reduced episodes of both clinical and severe malaria in children 5 to 17 months of age by approximately 50% in an ongoing phase 3 trial. We studied infants 6 to 12 weeks of age recruited for the same trial. METHODS: We administered RTS,S/AS01 or a comparator vaccine to 6537 infants who were 6 to 12 weeks of age at the time of the first vaccination in conjunction with Expanded Program on Immunization (EPI) vaccines in a three-dose monthly schedule. Vaccine efficacy against the first or only episode of clinical malaria during the 12 months after vaccination, a coprimary end point, was analyzed with the use of Cox regression. Vaccine efficacy against all malaria episodes, vaccine efficacy against severe malaria, safety, and immunogenicity were also assessed. RESULTS: The incidence of the first or only episode of clinical malaria in the intention-to-treat population during the 14 months after the first dose of vaccine was 0.31 per person-year in the RTS,S/AS01 group and 0.40 per person-year in the control group, for a vaccine efficacy of 30.1% (95% confidence interval [CI], 23.6 to 36.1). Vaccine efficacy in the per-protocol population was 31.3% (97.5% CI, 23.6 to 38.3). Vaccine efficacy against severe malaria was 26.0% (95% CI, -7.4 to 48.6) in the intention-to-treat population and 36.6% (95% CI, 4.6 to 57.7) in the per-protocol population. Serious adverse events occurred with a similar frequency in the two study groups. One month after administration of the third dose of RTS,S/AS01, 99.7% of children were positive for anti-circumsporozoite antibodies, with a geometric mean titer of 209 EU per milliliter (95% CI, 197 to 222). CONCLUSIONS: The RTS,S/AS01 vaccine coadministered with EPI vaccines provided modest protection against both clinical and severe malaria in young infants. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619.).
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“There is only one malaria vaccine candidate that has received a positive regulatory assessment: RTS,S/AS01 (RTS,S) (Mosquirix), which is an injectable vaccine that provides partial protection against malaria in young children 115 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [115]
In the citing paper
“The antigen is formulated as virus-like particle and combined with a liposomal adjuvant system.”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [115]
In the citing paper
“In July 2015, European regulators approved the use of the vaccine, although it is at most 50% effective 115 .”
From Nanotechnology approaches for global infectious diseases (2021) · cites this paper as [115]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Modeling Survival Data: Extending the Cox Model
Therneau, T. M., & Grambsch, P. M. (2000) · Statistics for Biology and Health · doi:10.1007/978-1-4757-3294-8 · Cited by 8,674
Pushko, P., Pumpens, P., & Grens, E. (2013) · Intervirology · doi:10.1159/000346773 · Cited by 5,975
First Results of Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Children
The RTS, S. C. T. P. (2011) · New England Journal of Medicine · doi:10.1056/nejmoa1102287 · Cited by 896
Self-citationICH Harmonised Tripartite Guideline: Guideline for Good Clinical Practice.
Bhuiyan, P. S., & Rege, N. N. (2001) · PubMed · Cited by 527
Kester, K. E., Cummings, J. F., Ofori‐Anyinam, O., Ockenhouse, C. F., Krzych, U., Moris, P., Schwenk, R., Nielsen, R. A., Debebe, Z., Pinelis, E., et al. (2009) · The Journal of Infectious Diseases · doi:10.1086/600120 · Cited by 524
Siegrist, C. (2003) · Vaccine · doi:10.1016/s0264-410x(03)00342-6 · Cited by 350
Design and Analysis of Vaccine Studies
Halloran, M. E., Longini, I. M., & Struchiner, C. J. (2009) · Statistics for biology and health · doi:10.1007/978-0-387-68636-3 · Cited by 332
Aponte, J. J., Aide, P., Renom, M., Mandomando, I., Bassat, Q., Sacarlal, J., Manaca, M. N., Lafuente, S., Barbosa, A., Leach, A., et al. (2007) · The Lancet · doi:10.1016/s0140-6736(07)61542-6 · Cited by 279
Glycoconjugate vaccines and immune interference: A review
Dagan, R., POOLMAN, J. T., & Siegrist, C. (2010) · Vaccine · doi:10.1016/j.vaccine.2010.06.026 · Cited by 270
Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants
Abdulla, S., Oberholzer, R., Juma, O. A., Kubhoja, S. D., Machera, F., Membi, C. D., Omari, S., Urassa, A., Mshinda, H., Jumanne, A., et al. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0807773 · Cited by 239
Olotu, A., Lusingu, J., Leach, A. J., Lievens, M., Vekemans, J., Msham, S., Lang, T. A., Gould, J. H. M., Dubois, M., Jongert, E., et al. (2011) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(10)70262-0 · Cited by 169
Asante, K. P., Abdulla, S., Agnandji, S. T., Lyimo, J., Vekemans, J., Soulanoudjingar, S., Owusu, R., Shomari, M., Leach, A. J., Jongert, E., et al. (2011) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(11)70100-1 · Cited by 163
Steketee, R. W., & Campbell, C. C. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-299 · Cited by 151
Insel, R. A. (1995) · Annals of the New York Academy of Sciences · doi:10.1111/j.1749-6632.1995.tb44436.x · Cited by 125
Defining Childhood Severe Falciparum Malaria for Intervention Studies
Bejon, P., Berkley, J. A., Mwangi, T., Ogada, E. A., Mwangi, I., Maitland, K., Williams, T. N., Scott, J. A. G., English, M., Lowe, B. S., et al. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040251 · Cited by 112
Bonhoeffer, J., Menkes, J. H., Gold, M., Brito, G. D. S., Fisher, M. C., Halsey, N. A., & Vermeer, P. (2003) · Vaccine · doi:10.1016/j.vaccine.2003.09.008 · Cited by 110
Agnandji, S. T., Asante, K. P., Lyimo, J., Vekemans, J., Soulanoudjingar, S., Owusu, R., Shomari, M., Leach, A. J., Fernandes, J. F., Dosoo, D., et al. (2010) · The Journal of Infectious Diseases · doi:10.1086/656190 · Cited by 103
The analysis of malaria parasite rates in infants.
MacDonald, G. F. (1950) · PubMed · Cited by 99
Swysen, C., Vekemans, J., Bruls, M., Oyakhirome, S., DRAKELEY, C. J., Kremsner, P. G., Greenwood, B. M., Ofori‐Anyinam, O., Okech, B. A., Villafana, T. L., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-223 · Cited by 98
Lell, B., Agnandji, S., von Glasenapp, I., Haertle, S., Oyakhiromen, S., Issifou, S., Vekemans, J., Leach, A., Lievens, M., Dubois, M., et al. (2009) · PLoS ONE · doi:10.1371/journal.pone.0007611 · Cited by 89
Leach, A. J., Vekemans, J., Lievens, M., Ofori‐Anyinam, O., Cahill, C. P., Owusu‐Agyei, S., Abdulla, S., Macete, E., Njuguna, P., Savarese, B., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-224 · Cited by 75
Vaccination of neonates: Problem and issues
Hodgins, D. C., & Shewen, P. E. (2011) · Vaccine · doi:10.1016/j.vaccine.2011.12.047 · Cited by 72
White, M. T., Griffin, J. T., DRAKELEY, C. J., & Ghani, A. C. (2010) · Malaria Journal · doi:10.1186/1475-2875-9-82 · Cited by 58
An analysis of malaria parasite rates in infants: 40 years after Macdonald.
Brabin, B. J. (1990) · Tropical Diseases Bulletin · Cited by 46
Clément, F., Dewar, V., Braeckel, E. V., Desombere, I., Dewerchin, M., Swysen, C., Demoitié, M., Jongert, E., Cohen, J., Leroux-Roels, G. G., et al. (2012) · Malaria Journal · doi:10.1186/1475-2875-11-384 · Cited by 44
Lievens, M., Aponte, J. J., Williamson, J. M., Mmbando, B. P., Mohamed, A., Bejon, P., & Leach, A. J. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-222 · Cited by 32
Vekemans, J., Marsh, K., Greenwood, B. M., Leach, A. J., Kaboré, W., Soulanoudjingar, S., Asante, K. P., Ansong, D., Evans, J., Sacarlal, J., et al. (2011) · Malaria Journal · doi:10.1186/1475-2875-10-221 · Cited by 32
Beigel, J. H., Kohl, K. S., Khuri-Bulos, N. A., Bravo, L. C., Nell, P., Marcy, S. M., Warschaw, K. E., Ong‐Lim, A. L., Poerschke, G., Weston, W., et al. (2007) · Vaccine · doi:10.1016/j.vaccine.2007.02.066 · Cited by 29
Pooled analysis of safety data from pediatric Phase II RTS,S/AS malaria candidate vaccine trials
Vekemans, J., Guerra, Y., Lievens, M., Benns, S., Lapierre, D., Leach, A. J., & Verstraeten, T. (2011) · Human Vaccines · doi:10.4161/hv.7.12.18046 · Cited by 15
Clinical experience with DTPw-HBV and DTPw-HBV/Hib combination vaccines
Prymula, R., & Plíšek, S. (2008) · Expert Opinion on Biological Therapy · doi:10.1517/14712598.8.4.503 · Cited by 9
Flagged first, then by citations
1 of the 31 references couldn’t be matched to a known paper.
Research works printed but not linked: 1
- Brabin B, 1990, Trop Dis Bull, 87, R1
Cited by
Sorted by citations
Liu, L., Oza, S., Hogan, D., Perin, J., Rudan, I., Lawn, J. E., Cousens, S., Mathers, C., & Black, R. E. (2015) · The Lancet · doi:10.1016/s0140-6736(14)61698-6 · Cited by 3,167
A guide to vaccinology: from basic principles to new developments
Pollard, A. J., & Bijker, E. M. (2021) · Nature Reviews Immunology · doi:10.1038/s41577-020-00479-7 · Cited by 1,593
Key roles of adjuvants in modern vaccines
Reed, S. G., Orr, M. T., & Fox, C. B. (2013) · Nature Medicine · doi:10.1038/nm.3409 · Cited by 1,478
White, N. J., Pukrittayakamee, S., Hien, T. T., Faiz, M. A., Mokuolu, O. A., & Dondorp, A. M. (2013) · The Lancet · doi:10.1016/s0140-6736(13)60024-0 · Cited by 1,220
Metadata
- Authors
- The RTS, S. C. T. P.
- Affiliations
- Program for Appropriate Technology in Health (US)
- Corresponding author
- The RTS,S Clinical Trials Partnership
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-12-13
- Volume
- 367
- Issue
- 24
- Pages
- 2284-2295
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC10915853
- OpenAlex
- W2244674613
- Cited by
- 752
- References
- 31
- Citations by year
- 2026: 18 · 2025: 29 · 2024: 35 · 2023: 38 · 2022: 36 · 2021: 42 · 2020: 45 · 2019: 47 · 2018: 40 · 2017: 58 · 2016: 67 · 2015: 74 · 2014: 111 · 2013: 103 · 2012: 7
- FWCI
- 91.09
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- other-oa
- Locations
- New England Journal of Medicine (publishedVersion, other-oa)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- IHI Repository (acceptedVersion)
- PubMed Central (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Funders
- Bill and Melinda Gates Foundation
- GlaxoSmithKline
- Wellcome Trust (092654)
- National Institutes of Health (CC999999)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
- Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Travel-related health issues
- Keywords
- RTS,S/AS01, malaria vaccine, infants, vaccine efficacy, clinical malaria, severe malaria, circumsporozoite protein, co-administration, immunogenicity, vaccine safety, Plasmodium falciparum, African infants, malaria prevention, vaccine adverse events
- MeSH terms
- Africa, Female, Humans, Immunization Schedule, Infant, Male, Plasmodium falciparum, Vaccines, Synthetic, Incidence, Proportional Hazards Models, Malaria, Falciparum, Treatment Outcome, Malaria Vaccines, Intention to Treat Analysis
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
