3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
The thirty-six-month immunogenicity evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese female subjects aged 9 to 45 years and male subjects aged 9 to 15 years.
Anogenital Human Papilloma Virus Infection
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||The Thirty-six-Month Immunogenicity Evaluation of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 45 Years and Male Subjects Aged 9 to 15 Years|
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2012|
People that receive HPV vaccine in V501-030
All eligible subjects will be enrolled for one visit. A medical history and physical examination will be conducted on all subjects. A 10 mL blood specimen will be collected. All Sera should be shipped to PPD Vaccines and Biologics Laboratory in the US. The serum specimen will be tested at PPD Laboratory with competitive Luminex immunoassay (cLIA) and multiplexed HPV immunoassay. The purpose of the quadrivalent HPV cLIA and multiplex is to detect neutralizing antibody and total IgG to HPV virus-like particles (VLPs), serotypes 6, 11, 16, 18, respectively.
|Contact: Rongcheng Li, MD||86 0771 firstname.lastname@example.org|
|Liuzhou CDC||Not yet recruiting|
|Liuzhou, Guangxi, China, 530028|
|Contact: Youping Liu|
|Principal Investigator:||Rongcheng Li, MD||Guangxi CDC|