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3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

This study is not yet open for participant recruitment.
Verified September 2011 by Guangxi Center for Disease Control and Prevention
Sponsor:
Information provided by (Responsible Party):
Rongcheng Li, Guangxi Center for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01427777
First received: September 1, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 1, 2011
September 1, 2011
September 2011
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No Changes Posted
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3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Subjects who participated in V501-030 in Per-protocol population
Anogenital Human Papilloma Virus Infection
Not Provided
HPV Vaccine
People that receive HPV vaccine in V501-030
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
June 2012
Not Provided

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
Both
9 Years to 45 Years
Yes
Contact: Rongcheng Li, MD 86 0771 2518986 lrch2001@163.com
China
 
NCT01427777
V501-030-1
No
Rongcheng Li, Guangxi Center for Disease Control and Prevention
Guangxi Center for Disease Control and Prevention
Not Provided
Principal Investigator: Rongcheng Li, MD Guangxi CDC
Guangxi Center for Disease Control and Prevention
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP