3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

NCT ID: NCT01427777

Last Updated: 2011-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-06-30

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.

Conditions

Anogenital Human Papilloma Virus Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

HPV Vaccine

People that receive HPV vaccine in V501-030

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangxi Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: lead

Responsible Party

Rongcheng Li

Director of Vaccine Research Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rongcheng Li, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi CDC

Locations

Liuzhou CDC

Liuzhou, Guangxi, China

Countries

China

Central Contacts

Rongcheng Li, MD

Role: CONTACT

lrch2001@163.com

86 0771 2518986

Facility Contacts

Youping Liu

Role: primary

References

Huang T, Liu Y, Li Y, Liao Y, Shou Q, Zheng M, Liao X, Li R. Evaluation on the persistence of anti-HPV immune responses to the quadrivalent HPV vaccine in Chinese females and males: Up to 3.5 years of follow-up. Vaccine. 2018 Mar 7;36(11):1368-1374. doi: 10.1016/j.vaccine.2018.02.006. Epub 2018 Feb 7.

Reference Type: DERIVED

PMID: 29428178 (View on PubMed)

Other Identifiers

V501-030-1

Identifier Type: -

Identifier Source: org_study_id