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Title: Immunogenicity and safety of a 9-valent HPV vaccine
Authors: Pierre Van Damme
Sven Eric Olsson
Stanley Block
Xavier Castellsague
Glenda E. Gray
Teobaldo Herrera
Li Min Huang
Dong Soo Kim
Punnee Pitisuttithum
Joshua Chen
Susan Christiano
Roger Maansson
Erin Moeller
Xiao Sun
Scott Vuocolo
Alain Luxembourg
Universiteit Antwerpen
Danderyd Hospital
Kentucky Pediatric Research Institute
Institute Catala Oncologia
University of Witwatersrand
Instituto de Investigation Nutricional
National Taiwan University College of Medicine
Yonsei University College of Medicine
Mahidol University
Merck & Co., Inc.
Keywords: Medicine
Issue Date: 1-Jul-2015
Citation: Pediatrics. Vol.136, No.1 (2015), e28-e39
Abstract: © 2015 by the American Academy of Pediatrics. OBJECTIVES: Prophylactic vaccination of youngwomen aged 16 to 26 years with the 9-valent (6/11/16/18/31/33/45/52/58) human papillomavirus (HPV) virus-like particle (9vHPV) vaccine prevents infection and disease. We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged 9 to 15 years. METHODS: Subjects (N = 3066) received a 3-dose regimen of 9vHPV vaccine administered at day 1, month 2, and month 6. Anti-HPV serologic assays were performed at day 1 and month 7. Noninferiority required that the lower bound of 2-sided 95% confidence intervals of geometric mean titer ratios (boys:young women or girls:young women) be.0.67 for each HPV type. Systemic and injection-site adverse experiences (AEs) and serious AEs were monitored. RESULTS: At 4 weeks after dose 3,.99% of girls, boys, and young women seroconverted for each vaccine HPV type. Increases in geometric mean titers to HPV types 6/11/16/18/31/33/45/52/58 were elicited in all vaccine groups. Responses in girls and boys were noninferior to those of young women. Persistence of anti-HPV responses was demonstrated through 2.5 years after dose 3. Administration of the 9vHPV vaccine was generally well tolerated. A lower proportion of girls (81.9%) and boys (72.8%) than young women (85.4%) reported injection-site AEs, most of which were mild to moderate in intensity. CONCLUSIONS: These data support bridging the efficacy findings with 9vHPV vaccine in young women 16 to 26 years of age to girls and boys 9 to 15 years of age and implementing genderneutral HPV vaccination programs in preadolescents and adolescents.
ISSN: 10984275
Appears in Collections:Scopus 2011-2015

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