Status:

UNKNOWN

3-year Immunogenicity Evaluation of Quadrivalent HPV Vaccine in China

Lead Sponsor:

Guangxi Center for Disease Control and Prevention

Conditions:

Anogenital Human Papilloma Virus Infection

Eligibility:

All Genders

9-45 years

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 ...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2012

Estimated Enrollment :

300 Patients enrolled

Trial Details

Trial ID

NCT01427777

Start Date

September 1 2011

End Date

June 1 2012

Last Update

September 2 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Liuzhou CDC

Liuchow, Guangxi, China, 530028