3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

September 1, 2011 updated by: Rongcheng Li, Guangxi Center for Disease Control and Prevention

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Liuzhou, Guangxi, China, 530028
        • Liuzhou CDC
        • Contact:
          • Youping Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who participated in V501-030 in Per-protocol population

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HPV Vaccine
People that receive HPV vaccine in V501-030

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Center for Disease Control and Prevention

Investigators

  • Principal Investigator: Rongcheng Li, MD, Guangxi CDC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

September 1, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (Estimate)

September 2, 2011

Study Record Updates

Last Update Posted (Estimate)

September 2, 2011

Last Update Submitted That Met QC Criteria

September 1, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V501-030-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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