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Pediatrics. 2017 Dec;140(6). pii: e20163947. doi: 10.1542/peds.2016-3947.

4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years.

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Department of Obstetrics and Gynecology, Augusta University, Augusta, Georgia.
Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand.
Kentucky Pediatric and Adult Research Inc, Bardstown, Kentucky.
Centro de Investigación en Salud Poblacional, Instituto Nacional de Salud Pública, Cuernavaca, Morelos, Mexico.
Fundación Centro de Investigación Clínica, Medellín, Colombia.
Coordinating Research Centre, Frederiksberg Hospital, Frederiksberg, Denmark.
Department of Pediatrics, Sanford School of Medicine, University of South Dakota and Sanford Children's Specialty Clinics, Sioux Falls, South Dakota.
Department of Clinical Science, University of Bergen and Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway; and.
Merck & Company Inc, Kenilworth, New Jersey.
Merck & Company Inc, Kenilworth, New Jersey



We describe the final 10-year data for the long-term follow-up study of the 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents.


In the base study (V501-018), 1661 sexually inactive boys and girls received the 4vHPV vaccine (early vaccination group [EVG], managed for 9.9 years) or a placebo at day 1, month 2, and month 6. Thereafter, at month 30, the placebo group (catch-up vaccination group [CVG], managed for 7.4 years) received the 4vHPV vaccine by using the same dosing schedule. Long-term anti-HPV type 6, 11, 16, and 18 immune responses were assessed. Effectiveness was estimated by calculating the incidence rate of the primary endpoints (HPV types 6, 11, 16, and 18-related disease or persistent infection).


For HPV types 6, 11, and 16, 89% to 96% of subjects remained seropositive through 10-years postvaccination. The preadolescents had 38% to 65% higher geometric mean titers at month 7, which remained 16% to 42% higher at 10 years compared with adolescents. No cases of HPV type 6, 11, 16, and 18-related diseases were observed. Ten subjects had a persistent infection of ≥6 months duration with vaccine-type HPV and 2 subjects had persistent infection for ≥12 months. No new serious adverse events were reported through 10 years.


A 3-dose regimen of the 4vHPV vaccine was immunogenic, clinically effective, and generally well tolerated in preadolescents and adolescents during 10 years of follow-up. These long-term findings support efforts to vaccinate this population against HPV before exposure.

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Conflict of interest statement

POTENTIAL CONFLICT OF INTEREST: Dr Ferris has received grant support from Merck & Company Inc (Kenilworth, NJ) through his institution and personal fees for consultancy and advisory boards for Merck & Company; Drs Block and Lazcano-Ponce have received research grants from and are members of a speaker’s bureau for Merck & Company and have served as paid expert witnesses and consultants for Merck & Company; Dr Mehlsen has received funding from Merck & Company to conduct human papillomavirus–vaccine clinical trials; Dr Chatterjee has received funding from Merck & Company and GlaxoSmithKline to conduct human papillomavirus–vaccine clinical trials and served on a speaker’s bureau for Merck & Company; Dr Iversen has received compensation from Merck & Company to conduct vaccine clinical trials and for scientific advisory board fees; Drs Joshi, Chu, Krick-Likos, Saah, and Das are employees of Merck Sharp & Dohme Corporation, a subsidiary of Merck & Company and may hold stock options; the other authors have indicated they have no potential conflicts of interest to disclose.

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