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Sponsored by: |
Merck |
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Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00337428 |
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 |
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Neoplasms, Glandular and Epithelial Diphtheria Tetanus Whooping Cough Poliomyelitis |
Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment 7 Months |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Gardasil (V501) Given Concomitantly With REPEVAX(TM) in Healthy Adolescents 11-17 Years of Age |
Ages Eligible for Study: | 11 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2005_093, V501-024 |
Study First Received: | June 14, 2006 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00337428 |
Health Authority: | Denmark: Danish Medicines Agency |
Bacterial Infections Spinal Cord Diseases Whooping Cough Healthy Tetanus Whooping cough Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Infections Respiratory Tract Diseases Motor Neuron Disease Picornaviridae Infections |
Cough Central Nervous System Diseases Diphtheria Degenerative motor system disease Motor neuron disease Virus Diseases Central Nervous System Infections Poliomyelitis Myelitis Enterovirus Infections Clostridium Infections Neoplasms, Glandular and Epithelial |
Bordetella Infections RNA Virus Infections Neoplasms Neoplasms by Histologic Type Corynebacterium Infections |
Nervous System Diseases Central Nervous System Viral Diseases Infection Actinomycetales Infections |