The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.
Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents: A Randomized Controlled Trial
Abstract
OBJECTIVE: Administration of a quadrivalent HPV-6/ 1/16/18 vaccine to 16- to 26-year-old women was highly effective in preventing HPV-6/ 1/16/18-related cervical/vulvar/vaginal precancerous lesions and genital warts. As the risk of acquiring HPV significantly rises after sexual debut, HPV vaccines should have the greatest benefit in sexually naive adolescents. We evaluated the tolerability and immunogenicity of quadrivalent vaccine in males and females 9 to 15 years of age through 18 months postenrollment. METHODS: In this randomized, double-blind trial, 1781 sexually naive children were assigned (2:1) to quadrivalent HPV-6/11/16/18 vaccine or saline placebo administered at day 1 and months 2 and 6. Serum neutralizing anti-HPV-6/11/16/18 responses were summarized as geometric mean titers (GMTs) and seroconversion rates. Primary analyses were done per-protocol (subjects received 3 doses, had no major protocol violations and were HPV type-specific seronegative at day 1). Adverse experiences were collected by diary card. RESULTS: At month 7, seroconversion rates were > or =99.5% for the 4 vaccine-HPV-types. GMTs and seroconversion rates in boys were noninferior to those in girls (P < 0.001). At month 18, > or =91.5% of vaccine recipients were seropositive, regardless of gender. A higher proportion of vaccine recipients (75.3%) than placebo recipients (50.0%) reported one or more injection-site adverse experiences following any vaccination. Rates of fever were similar between vaccination groups. No serious vaccine-related adverse experiences were reported. CONCLUSIONS: In 9- to 15-year-old adolescents, the quadrivalent vaccine was generally well tolerated and induced persistent anti-HPV serologic responses in the majority of subjects for at least 12 months following completion of a three-dose regimen. The vaccine durability supports universal HPV vaccination programs in adolescents to reduce the burden of clinical HPV disease, particularly cervical cancer and precancers.
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Epidemiologic classification of human papillomavirus types associated with cervical cancer
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Self-citationSexually Transmitted Diseases Among American Youth: Incidence and Prevalence Estimates, 2000
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Self-citationSexual behaviour in Britain: early heterosexual experience
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Self-citationHPV prophylactic vaccines and the potential prevention of noncervical cancers in both men and women
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Metadata
- Authors
- Reisinger, K. S., Block, S. L., Lazcano-Ponce, E., Samakoses, R., Esser, M. T., Erick, J., Puchalski, D., Giacoletti, K. E. D., Sings, H. L., Lukac, S., Alvarez, F. B., & Barr, E.
- Venue
- Pediatric Infectious Disease Journal
- Published
- 2007-03
- Volume
- 26
- Issue
- 3
- Pages
- 201-209
- ISSN
- 0891-3668 (ISSN-L)
- OpenAlex
- W2040680109
- Cited by
- 296
- References
- 25
- FWCI
- 25.54
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents: A Randomized Controlled Trial. https://app.cochat.ai/papers/10.1097/01.inf.0000253970.29190.5a
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- Reisinger, K. S., Block, S. L., Lazcano-Ponce, E., Samakoses, R., Esser, M. T., Erick, J., Puchalski, D., Giacoletti, K. E. D., Sings, H. L., Lukac, S., Alvarez, F. B., & Barr, E. (2007). Safety and Persistent Immunogenicity of a Quadrivalent Human Papillomavirus Types 6, 11, 16, 18 L1 Virus-Like Particle Vaccine in Preadolescents and Adolescents: A Randomized Controlled Trial. Pediatric Infectious Disease Journal. https://doi.org/10.1097/01.inf.0000253970.29190.5a
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
