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A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine


Phase 3
10 Years
23 Years
Not Enrolling
Both
Cervical Cancer, Genital Warts

Thank you

Trial Information

A Study to Demonstrate Immunogenicity and Tolerability of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents, and To Determine End-Expiry Specifications for the Vaccine


Inclusion Criteria:



- Healthy adolescents and pre-adolescents with no prior sexual history

- Healthy women who have an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

- Prior Human Papillomavirus (HPV) vaccination

- Prior abnormal Paps

- Prior history of genital warts

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3

Outcome Description:

Seroconversion is defined as going from seronegative to seropositive. Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL).

Outcome Time Frame:

Week 4 Postdose 3 (Month 7)

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

V501-016

NCT ID:

NCT00092495

Start Date:

December 2002

Completion Date:

September 2004

Related Keywords:

  • Cervical Cancer
  • Genital Warts
  • Uterine Cervical Neoplasms
  • Condylomata Acuminata

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