1. Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: a randomized, double-blind, placebo-controlled trial in Chinese males and females.
- Author
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Li R, Li Y, Radley D, Liu Y, Huang T, Sings HL, Zhang L, Wang W, Zhong X, and Saah AJ
- Subjects
- Adolescent, Adult, Antibodies, Viral blood, Child, China, Double-Blind Method, Female, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, Humans, Male, Middle Aged, Papillomavirus Vaccines administration & dosage, Placebos administration & dosage, Young Adult, Papillomaviridae immunology, Papillomavirus Infections prevention & control, Papillomavirus Infections virology, Papillomavirus Vaccines adverse effects, Papillomavirus Vaccines immunology
- Abstract
In this randomized, double-blind, placebo-controlled trial, 9-15 year old Chinese males (n=100) and 9-45 year old Chinese females (n=500) from Wuzhou, Guangxi, China were randomized (1:1) to receive either quadrivalent HPV vaccine or adjuvant-containing placebo. Blood samples were obtained at day 1 and one month post-dose 3 to determine the level of vaccine-induced antibodies. Among vaccine recipients, high antibody levels were observed for each of the four HPV types and seroconversion was >96%. The vaccine was generally well tolerated, with no vaccine-related serious adverse events. This study demonstrated that the quadrivalent HPV vaccine is highly immunogenic and generally well tolerated among Chinese males and females., (Copyright © 2012 Elsevier Ltd. All rights reserved.)
- Published
- 2012
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