3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

• Conditions: Anogenital Human Papilloma Virus Infection

• Registration Number: NCT01427777
• Lead Sponsor: Guangxi Center for Disease Control and Prevention

Brief 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.

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-01
• Last Update Submitted: 2011-09-01
• Study First Posted: 2011-09-02
• Last Update Posted: 2011-09-02
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Healthy Chinese subject who participated in V501-030 in Per-protocol population.
• Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
• Subject is willing to give consent/assent.

Exclusion Criteria

• Subject is concurrently enrolled in clinical studies of investigational agents which may interfere with the evaluation of the study objectives.
• Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives
• Subject has a history of known prior vaccination with a HPV vaccine, either active agent or placebo after receiving the vaccination during V501-030

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Liuzhou CDC; 🇨🇳 Liuzhou, Guangxi, China