3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

Guangxi Center for Disease Control and Prevention300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Anogenital Human Papilloma Virus Infection

Eligibility

Sex: ALLMin age: 9 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Liuzhou CDC

Liuchow, Guangxi, China

Central Contacts

Rongcheng Li, MD

CONTACT

86 0771 2518986 lrch2001@163.com

Data from ClinicalTrials.gov

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