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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


N/A
9 Years
45 Years
Not Enrolling
Both
Anogenital Human Papilloma Virus Infection

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Rongcheng Li, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Guangxi CDC

Authority:

China: Food and Drug Administration

Study ID:

V501-030-1

NCT ID:

NCT01427777

Start Date:

September 2011

Completion Date:

June 2012

Related Keywords:

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

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