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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00411749
First received: December 14, 2006
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411749

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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 May 22, 2013