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Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001 AM2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00543543
First received: October 12, 2007
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the safety, efficacy, and immunogenicity of V503 in comparison to GARDASIL.


Condition Intervention Phase
Cervical Cancer
Vulvar Cancer
Vaginal Cancer
Genital Warts
Human Papillomavirus Infection
 Biological: Comparator: GARDASIL(R)
Biological: Experimental: V503
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Incidence of HPV-related cervical, vaginal or vulvar disease [ Time Frame: Up to end of study ] [ Designated as safety issue: No ]
  • Geometric mean titers (GMTs) to HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined incidence of HPV-related persistent infection from two or more consecutive visits [ Time Frame: Up to end of study ] [ Designated as safety issue: No ]
  • Seroconversion percentages to HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 14620
Study Start Date: September 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Part A: Arm 1
GARDASIL(R) 0.5 mL injection in 3 dose regimen
 Biological: Comparator: GARDASIL(R)
GARDASIL(R) 0.5 mL injection in 3 dose regimen
Experimental: Part A: Arm 2
V503 0.5 mL injection in 3 dose regimen
 Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Experimental: Part A: Arm 3
V503 0.5 mL injection in 3 dose regimen
 Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Experimental: Part A: Arm 4
V503 0.5 mL injection in 3 dose regimen
 Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Experimental: Part B: Arm 1
V503 (dose to be selected after Part A is complete) in 3 dose regimen
 Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Active Comparator: Part B: Arm 2
GARDASIL(R) 0.5 mL injection in 3 dose regimen
 Biological: Comparator: GARDASIL(R)
GARDASIL(R) 0.5 mL injection in 3 dose regimen

  Eligibility

Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female between 16- to 26-years-old
  • Has never had Pap testing or has only had normal Pap test results

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 any illegal drugs or an alcohol abuser
  • History of severe allergic reaction that required medical attention
  • Are pregnant
  • Received marketed HPV vaccine or participated in an HPV trial
  • 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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543543

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00543543     History of Changes
Other Study ID Numbers: 2007_538, V503-001
Study First Received: October 12, 2007
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Condylomata Acuminata
Vaginal Neoplasms
Vulvar Neoplasms
Warts
Papillomavirus Infections
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Vaginal Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on May 23, 2013