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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543543
First received: October 12, 2007
Last updated: August 7, 2014
Last verified: August 2014
  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
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Incidence of HPV-related cervical, vaginal or vulvar disease [ Time Frame: Up to Month 54 ] [ Designated as safety issue: No ]
  • Geometric mean titers (GMTs) to HPV types contained in the vaccine [ Time Frame: 4 weeks postdose 3 in Part B ] [ Designated as safety issue: No ]
  • GMTs to HPV types contained in the vaccine [ Time Frame: 7 days and 28 days postdose 4 in the extension study ] [ 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 Month 54 ] [ Designated as safety issue: No ]
  • Seroconversion percentages to HPV types contained in the vaccine [ Time Frame: 4 weeks postdose 3 in Part B ] [ Designated as safety issue: No ]

Estimated Enrollment: 14620
Study Start Date: September 2007
Estimated Study Completion Date: October 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Base Study Part A: GARDASIL
GARDASIL 0.5 mL injection in 3-dose regimen in the base study. Participants in this arm who receive ≥1 dose of GARDASIL in the base study can enter the extension study and receive a 3-dose regimen of V503 at the dose administered in Part B.
Biological: Comparator: GARDASIL
GARDASIL 0.5 mL injection in 3 dose regimen
Experimental: Base Study Part A: V503 Low Dose
V503 low dose, 0.5 mL injection in 3-dose regimen
Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Experimental: Base Study Part A: V503 Mid Dose
V503 mid dose, 0.5 mL injection in 3-dose regimen
Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Experimental: Base Study Part A: V503 High Dose
V503 high dose, 0.5 mL injection in 3-dose regimen
Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Experimental: Base Study Part B: V503
V503 (dose to be selected after Part A is complete) in 3-dose regimen. Approximately 150 participants in this arm will receive a fourth dose of V503 in the extension study.
Biological: Experimental: V503
V503 0.5 mL injection in 3 dose regimen
Active Comparator: Base Study Part B: GARDASIL
GARDASIL 0.5 mL injection in 3-dose regimen in the base study. Participants in this arm who receive ≥1 dose of GARDASIL in the base study can enter the extension study and receive a 3-dose regimen of V503 at the dose administered in Part B.
Biological: Comparator: GARDASIL
GARDASIL 0.5 mL injection in 3 dose regimen

Detailed Description:

The study includes a double-blind, dose-finding evaluation of a 3-dose regimen of 3 dose formulations of V503 and GARDASIL (Base Study Part A), a double-blind, safety/efficacy evaluation of a 3-dose regimen of the V503 dose formulation selected in Part A and GARDASIL (Base Study Part B), and an open-label extension consisting of 2 substudies: an evaluation of immune memory in participants receiving a fourth vaccination with V503 (Extension Cohort 1) and an opportunity for participants who received GARDASIL in the base study to receive a 3-dose regimen of V503 (Extension Cohort 2).

  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
  • For the immune memory substudy in the extension (Cohort 1): was randomized to V503 in Part B of the base study and was in the per-protocol immunogenicity population for ≥1 HPV type
  • For the 3-dose V503 vaccination substudy in the extension (Cohort 2): was randomized to GARDASIL in either Part A or Part B of the base study and received ≥1 dose of GARDASIL

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543543

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00543543     History of Changes
Other Study ID Numbers: V503-001, 2007_538
Study First Received: October 12, 2007
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
DNA Virus Infections
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Tumor Virus Infections
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Vaginal Diseases
Virus Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on November 20, 2014