3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

Guangxi Center for Disease Prevention and Control

Status: Unknown

Conditions: Anogenital Human Papilloma Virus Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01427777

V501-030-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 9 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

HPV Vaccine

Description:

People that receive HPV vaccine in V501-030