Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337428
First received: June 14, 2006
Last updated: March 31, 2014
Last verified: March 2014

June 14, 2006
March 31, 2014
May 2006
May 2007   (final data collection date for primary outcome measure)
  • Number of Subjects Who Seroconverted for HPV Type 6 (HPV 6 ≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Subjects Who Seroconverted for HPV Type 11 (HPV 11 ≥ 16 mMU/mL) by Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Subjects Who Seroconverted for HPV Type 16 (HPV 16 ≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Subjects Who Seroconverted for HPV Type 18 (HPV 18≥ 20 mMU/mL) by Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Number of Subjects Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥ 0.1 IU/mL) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Number of Subjects Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥ 0.1 IU/mL) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥ 1:8) One Month Postvaccination With REPEVAX™ [ Time Frame: one month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥ 1:8) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Number of Subjects Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥ 1:8) One Month Postvaccination With REPEVAX™ [ Time Frame: one month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 6 at Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 11 at Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 16 at Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Anti-HPV 18 at Week 4 Postdose 3 of qHPV [ Time Frame: 7 Months (Week 4 Postdose 3) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Pertussis (Anti-PT) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Pertussis (Anti-FHA) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Pertussis (Anti-PRN) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for Pertussis (Anti-FIM) One Month Postvaccination With REPEVAX™ [ Time Frame: One month postvaccination with REPEVAX™ ] [ Designated as safety issue: No ]
Comparable (non-inferior) immunogenicity for all vaccine components
Complete list of historical versions of study NCT00337428 on ClinicalTrials.gov Archive Site
Not Provided
Acceptable safety profile
Not Provided
Not Provided
 
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX™ in Healthy Adolescents 11-17 Years of Age

Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Neoplasms, Glandular and Epithelial
  • Diphtheria
  • Tetanus
  • Whooping Cough
  • Poliomyelitis
  • Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
    GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
  • Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
    GARDASIL™ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6.
  • Biological: Comparator: REPEVAX™ (Concomitant)
    REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection.
  • Biological: Comparator: REPEVAX™ (Non-Concomitant)
    REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection.
  • Experimental: Group 1
    Concomitant/CMF
    Interventions:
    • Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
    • Biological: Comparator: REPEVAX™ (Concomitant)
  • Experimental: Group 2
    Non-Concomitant/CMF
    Interventions:
    • Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF)
    • Biological: Comparator: REPEVAX™ (Non-Concomitant)
  • Experimental: Group 3
    Concomitant/FMF
    Interventions:
    • Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
    • Biological: Comparator: REPEVAX™ (Concomitant)
  • Experimental: Group 4
    Non-Concomitant/FMF
    Interventions:
    • Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
    • Biological: Comparator: REPEVAX™ (Non-Concomitant)
Vesikari T,Van Damme P,Lindblad N,Pfletschinger U,Radley D,Ryan D,Vuocolo S,Haupt RM,Guris D . An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. . Pediatr Infect Dis J . 2010 Apr;29(4):314-8. PMID: 19952980

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
843
May 2007
May 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be healthy boys or girls, 11-17 years of age
  • Must be a virgin with no intention of becoming sexually active during the study period
  • Must have been properly vaccinated against diphtheria, tetanus, pertussis and polio

Exclusion Criteria:

  • Must not have received a vaccine against diphtheria, tetanus, pertussis and polio in the past 5 years
  • Must not have received any prior human papillomavirus (HPV) vaccine
Both
11 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00337428
V501-024, 2005_093
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP