June 14, 2006 |
February 5, 2009 |
May 2006 |
Comparable (non-inferior) immunogenicity for all vaccine components [ Time Frame: 7 months ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00337428 on ClinicalTrials.gov Archive Site |
Acceptable safety profile [ Time Frame: 7 months ] [ Designated as safety issue: No ] |
Same as current |
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Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents |
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. |
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Phase III |
Interventional |
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Neoplasms, Glandular and Epithelial
- Diphtheria
- Tetanus
- Whooping Cough
- Poliomyelitis
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- 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)
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- Experimental: Concomitant/CMF
- Experimental: Non-Concomitant/CMF
- Experimental: Concomitant/FMF
- Experimental: Non-Concomitant/FMF
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Completed |
843 |
February 2008 |
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
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Both |
11 Years to 17 Years |
Yes |
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NCT00337428 |
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
V501-024 |
Merck |
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Study Director: |
Medical Monitor |
Merck |
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Merck |
February 2009 |