S. M. GarlandP. PitisuttithumH. Y.S. NganC. H. ChoC. Y. LeeC. A. ChenY. C. YangT. Y. ChuN. F. TwuR. SamakosesY. TakeuchiT. H. CheungS. C. KimL. M. HuangB. G. KimY. T. KimK. H. KimY. S. SongS. LalwaniJ. H. KangM. SakamotoH. S. RyuN. BhatlaH. YoshikawaM. C. EllisonS. R. HanE. MoellerS. MurataM. RitterM. SawataC. ShieldsA. WaliaG. PerezA. LuxembourgIbaraki Prefectural Central HospitalBharati Vidyapeeth Medical College, PuneNational Taiwan University HospitalKeimyung University (KU), College of MedicineChang Gung Memorial HospitalEwha Womans University School of MedicineMackay Memorial Hospital TaiwanUniversity of MelbourneBuddhist Tzu-Chi General Hospital TaiwanJikei UniversitySungKyunKwan University, School of MedicineSeoul National UniversityVeterans General Hospital-TaipeiMahidol UniversityAll India Institute of Medical Sciences, New DelhiMerck & Co., Inc.Phramongkutklao College of MedicineThe University of Hong KongUniversity of Ulsan, College of MedicineThe Catholic University of KoreaChinese University of Hong KongAjou UniversityMSD K.K.Fukui General Hospital2019-08-282019-08-282018-06-05Journal of Infectious Diseases. Vol.218, No.1 (2018), 95-10815376613002218992-s2.0-85048443828https://repository.li.mahidol.ac.th/handle/20.500.14594/46592© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. 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.Mahidol UniversityMedicineArticleSCOPUS10.1093/infdis/jiy133