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Title: Efficacy, Immunogenicity, and Safety of a 9-Valent Human Papillomavirus Vaccine: Subgroup Analysis of Participants from Asian Countries
Authors: 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. Kang
M. 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
Ibaraki Prefectural Central Hospital
Bharati Vidyapeeth Medical College, Pune
National Taiwan University Hospital
Keimyung University (KU), College of Medicine
Chang Gung Memorial Hospital
Ewha Womans University School of Medicine
Mackay Memorial Hospital Taiwan
University of Melbourne
Buddhist Tzu-Chi General Hospital Taiwan
Jikei University
SungKyunKwan University, School of Medicine
Seoul National University
Veterans General Hospital-Taipei
Mahidol University
All India Institute of Medical Sciences, New Delhi
Merck & Co., Inc.
Phramongkutklao College of Medicine
The University of Hong Kong
University of Ulsan, College of Medicine
The Catholic University of Korea
Chinese University of Hong Kong
Ajou University
Fukui General Hospital
Keywords: Medicine
Issue Date: 5-Jun-2018
Citation: Journal of Infectious Diseases. Vol.218, No.1 (2018), 95-108
Abstract: © 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.
ISSN: 15376613
Appears in Collections:Scopus 2018

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