Publication: Immunogenicity and safety of a 9-valent HPV vaccine
Issued Date
2015-07-01
Resource Type
ISSN
10984275
00314005
00314005
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2-s2.0-84934325070
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Mahidol University
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SCOPUS
Bibliographic Citation
Pediatrics. Vol.136, No.1 (2015), e28-e39
Suggested Citation
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 Immunogenicity and safety of a 9-valent HPV vaccine. Pediatrics. Vol.136, No.1 (2015), e28-e39. doi:10.1542/peds.2014-3745 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/36397
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Title
Immunogenicity and safety of a 9-valent HPV vaccine
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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.