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
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.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Rongcheng Li, MD
Principal Investigator
Guangxi CDC
China: Food and Drug Administration
V501-030-1
NCT01427777
September 2011
June 2012
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