V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00411749
First received: December 14, 2006
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

The study evaluates the immunogenicity, safety and tolerability of V501 in preadolescent females


Condition Intervention Phase
HPV Infections
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
Biological: Comparator: Placebo (unspecified)
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 Immunogenicity Study in Females Aged 9 to 17 Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series [ 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 (GMT) 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".


  • Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series [ 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 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".


  • Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series [ 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 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".


  • Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series [ 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 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".



Secondary Outcome Measures:
  • HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series [ Time Frame: 24 month after completed vaccination series (Month 30) ] [ Designated as safety issue: No ]
    Month 30 HPV cLIA Geometric Mean Titers by vaccine group.


Enrollment: 107
Study Start Date: December 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V501
V501 vaccination Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Vaccine Injection cervix cancer exgenlesion Vaccination at Day 1, Month 2, and Month 6. Total 3 vaccinations. 0.5 mL intramuscular dose of V501 (HPV L1 Virus-Like Particle [VLP] Type 6, Type 11, Type 16, Type 18) or placebo at Day 1, Month 2 and Month 6.
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
V501; Gardasil, 0.5 ml injection in 3 dosing regimen
Other Names:
  • V501
  • Gardasil
Placebo Comparator: Placebo
Placebo vaccination, Placebo 0.5 ml injection in 3 dosing regimen
Biological: Comparator: Placebo (unspecified)
Placebo 0.5 ml injection in 3 dosing regimen

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Virginal Female Subject Aged 9 To 17 Years

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: NCT00411749

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00411749     History of Changes
Other Study ID Numbers: V501-028, 2006_052
Study First Received: December 14, 2006
Results First Received: July 19, 2010
Last Updated: May 13, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on September 30, 2014