3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

Anogenital Human Papilloma Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01427777
• Other study ID #: V501-030-1
• Status: Not yet recruiting
• Phase: N/A
• First received: September 1, 2011
• Last updated: September 1, 2011
• Start date: September 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2011
• Source: Guangxi Center for Disease Control and Prevention
• Contact: Rongcheng Li, MD
• Phone: 86 0771 2518986
• Email: lrch2001[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 45 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anogenital Human Papilloma Virus Infection
• Papillomavirus Infections
• Virus Diseases

Locations

Country	Name	City	State
China	Liuzhou CDC	Liuzhou	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Center for Disease Control and Prevention

Country where clinical trial is conducted

China,