NCT01427777

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Guangxi Center for Disease Control and Prevention · Other Government
• Sex: All
• Age: 9 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anogenital Human Papilloma Virus Infection

Timeline

• Start date: 2011-09-01
• Completion: 2012-06-01
• First posted: 2011-09-02
• Last updated: 2011-09-02

Locations

1 site across 1 country: China