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Sponsored by: |
Sanofi Pasteur MSD |
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Information provided by: | Sanofi Pasteur MSD |
ClinicalTrials.gov Identifier: | NCT00447525 |
Primary objective:
To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Poliomyelitis |
Biological: REVAXIS® Biological: DT-Polio® |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age |
Estimated Enrollment: | 734 |
Study Start Date: | February 2007 |
Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental | Biological: REVAXIS® |
2: Active Comparator | Biological: DT-Polio® |
Ages Eligible for Study: | 6 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Anne FIQUET, MD | SPMSD |
Responsible Party: | Sanofi Pasteur MSD ( Anne FIQUET MD ) |
Study ID Numbers: | F05-TdI-301 |
Study First Received: | March 12, 2007 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00447525 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Prevention of : Diphtheria, Tetanus and Poliomyelitis |
Bacterial Infections Spinal Cord Diseases Picornaviridae Infections Central Nervous System Diseases Diphtheria Tetanus Virus Diseases Gram-Positive Bacterial Infections |
Neuromuscular Diseases Central Nervous System Infections Poliomyelitis Myelitis Enterovirus Infections Clostridium Infections Degenerative Motor System Disease Motor Neuron Disease |
Bacterial Infections RNA Virus Infections Spinal Cord Diseases Nervous System Diseases Central Nervous System Diseases Picornaviridae Infections Central Nervous System Viral Diseases Diphtheria Tetanus Actinomycetales Infections |
Virus Diseases Gram-Positive Bacterial Infections Neuromuscular Diseases Central Nervous System Infections Poliomyelitis Corynebacterium Infections Myelitis Enterovirus Infections Clostridium Infections Motor Neuron Disease |