Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants from Asian Countries

S. M. Garland, P. Pitisuttithum, H. Y.S. Ngan, C. H. Cho, C. Y. Lee, C. A. Chen, Y. C. Yang, T. Y. Chu, N. F. Twu, R. Samakoses, Y. Takeuchi, T. H. Cheung, S. C. Kim, L. M. Huang, B. G. Kim, Y. T. Kim, K. H. Kim, Y. S. Song, S. Lalwani, J. H. KangM. Sakamoto, H. S. Ryu, N. Bhatla, H. Yoshikawa, M. C. Ellison, S. R. Han, E. Moeller, S. Murata, M. Ritter, M. Sawata, C. Shields, A. Walia, G. Perez, A. Luxembourg

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31 Scopus citations


Background A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002). Methods Participants (N = 2519) were vaccinated at day 1 and months 2 and 6. Gynecological samples (Study 001 only) and serum were collected for HPV DNA and antibody assessments, respectively. Injection-site and systemic adverse events (AEs) were monitored. Data were analyzed by country and vaccination group. Results 9vHPV vaccine prevented HPV-31/33/45/52/58-related persistent infection with 90.4%-100% efficacy across included countries. At month 7, ≥97.9% of participants seroconverted for each HPV type. Injection-site AEs occurred in 77.7%-83.1% and 81.9%-87.5% of qHPV and 9vHPV vaccine recipients in Study 001, respectively, and 62.4%-85.7% of girls/boys in Study 002; most were mild to moderate. Conclusions The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Asian participants. Data support 9vHPV vaccination programs in Asia. Clinical Trials Registration NCT00543543; NCT00943722.

Original languageEnglish
Pages (from-to)95-108
Number of pages14
JournalJournal of Infectious Diseases
Issue number1
StatePublished - 5 Jun 2018

Bibliographical note

Funding Information:
Acknowledgments. Medical writing support was provided by Erin Bekes, PhD, of Complete Medical Communications and was funded by Merck & Co., Inc., Kenilworth, NJ, USA.

Funding Information:
Financial support. This work was supported by Merck & Co., Inc., Kenilworth, NJ, USA.

Publisher Copyright:
© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America.


  • 9vHPV
  • Asia
  • cervical cancer
  • human papillomavirus
  • vaccine


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