V501 Efficacy Study in Women Aged 18 to 26 (V501-027)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00378560
First received: September 18, 2006
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

A study to evaluate the efficacy, immunogenicity, safety and tolerability of V501 in adult women


Condition Intervention Phase
HPV Infections
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Biological: Comparator: Placebo
Phase 2

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: V501 Phase II Efficacy Study in Women Aged 18 to 26

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Combined Incidence of Persistent Human Papillomavirus (HPV) 6, 11, 16 and 18 Infection or HPV 6, 11, 16 and 18 Related-Disease as Determined by Clinical/Pathologic Criteria and Positive Polymerase Chain Reaction (PCR) Assay for Virus Subtype [ Time Frame: Over 30 months ] [ Designated as safety issue: No ]
    Participants with HPV 6, 11, 16 or 18 persistent infection, and genital disease (e.g., cervical, vaginal or vulval intraepithelial neoplasia, or cancer, adenocarcinoma in situ and genital warts) per 100 person-years of follow up.


Secondary Outcome Measures:
  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 6) [ Time Frame: At one month after completed vaccination series (Month 7) ] [ Designated as safety issue: No ]

    Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMTs) by vaccine group.

    The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".


  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 11) [ Time Frame: At one month after completed vaccination series (Month 7) ] [ Designated as safety issue: No ]

    Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

    The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".


  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 16) [ Time Frame: At one month after completed vaccination series (Month 7) ] [ Designated as safety issue: No ]

    Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

    The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".


  • Vaccine Type Serum Antibody Titer at One Month After Completed Vaccination Series (Anti-HPV 18) [ Time Frame: At one month after completed vaccination series (Month 7) ] [ Designated as safety issue: No ]

    Month 7 HPV cLIA Geometric Mean Titers by vaccine group.

    The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".



Enrollment: 1021
Study Start Date: June 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
Biological: Comparator: Placebo
Placebo 0.5 ml injection in 3 dosing regimen
Experimental: 2
Vaccine
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Other Names:
  • V501
  • Gardasil

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female Subject Aged 18 To 26 Years
  • With 1-4 Lifetime Sexual Partners

Exclusion Criteria:

  • Male Subject
  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: NCT00378560

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

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00378560     History of Changes
Other Study ID Numbers: V501-027, 2006_032
Study First Received: September 18, 2006
Results First Received: April 21, 2010
Last Updated: March 31, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on August 21, 2014