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A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women


Phase 2
16 Years
26 Years
Not Enrolling
Female
Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection

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Trial Information

A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women


Inclusion Criteria:



- Females between 16- to 26-years-old

- Has never had Pap testing or has only had normal Pap test results.

- Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

- History of an abnormal cervical biopsy result

- History of a positive test for HPV; History of external genital/vaginal warts

- Currently a user of illegal drugs or an alcohol abuser

- History of severe allergic reaction that required medical attention

- Are pregnant

- Received a marketed HPV vaccine

- Currently enrolled in a clinical trial

- Currently has or has a history of certain medical conditions or is currently taking
or has taken certain medications (details will be discussed at the time of consent)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Geometric mean titers (GMTs) to HPV types contained in the administered vaccines

Outcome Time Frame:

4 weeks post dose 3

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2007_566

NCT ID:

NCT00551187

Start Date:

October 2007

Completion Date:

August 2009

Related Keywords:

  • Cervical Cancer
  • Vulvar Cancer
  • Vaginal Cancer
  • Genital Warts
  • Human Papillomavirus Infection
  • Uterine Cervical Neoplasms
  • Condylomata Acuminata
  • Vaginal Neoplasms
  • Vulvar Neoplasms
  • Warts
  • Papillomavirus Infections

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