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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00304265 |
Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.
To describe and characterize adverse events occurring after vaccination with COVAXiS or REPEVAX vaccine among two groups:Group 1 - adolescents 10-14 years of age who participated in study 371-03/01 (and thus received a 5th dose of Tripedia vaccine) and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life.
Condition | Intervention | Phase |
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Pertussis Diphtheria Tetanus Poliomyelitis |
Biological: Immunization with REPEVAX® or COVAXiS™ and IPV Merieux™" |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Enrollment: | 213 |
Study Start Date: | March 2006 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 10 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur Inc ( Medical Director ) |
Study ID Numbers: | TRI05 |
Study First Received: | March 16, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00304265 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Pertussis, Diphtheria, Tetanus, Poliomyelitis |
Bacterial Infections Spinal Cord Diseases Central Nervous System Diseases Picornaviridae Infections Whooping Cough Cough Degenerative motor system disease Diphtheria Tetanus Motor neuron disease Whooping cough Gram-Negative Bacterial Infections |
Virus Diseases Gram-Positive Bacterial Infections Neuromuscular Diseases Central Nervous System Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Myelitis Enterovirus Infections Clostridium Infections Motor Neuron Disease |
Bordetella Infections RNA Virus Infections Corynebacterium Infections Nervous System Diseases |
Central Nervous System Viral Diseases Infection Actinomycetales Infections |