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: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
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)
Biological: Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF)
Biological: Comparator: REPEVAX™ (Concomitant)
Biological: Comparator: REPEVAX™ (Non-Concomitant)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ]

Enrollment: 843
Study Start Date: May 2006
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Concomitant/CMF
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: 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.
Experimental: Group 2
Non-Concomitant/CMF
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: 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 3
Concomitant/FMF
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.
Experimental: Group 4
Non-Concomitant/FMF
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™ (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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00337428

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00337428     History of Changes
Other Study ID Numbers: V501-024, 2005_093
Study First Received: June 14, 2006
Results First Received: January 14, 2010
Last Updated: May 5, 2014
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Neoplasms
Diphtheria
Neoplasms, Glandular and Epithelial
Poliomyelitis
Tetanus
Tetany
Whooping Cough
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neoplasms by Histologic Type
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014