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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00355121 |
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.
The main objectives are:
Immunogenicity:
To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone.
Safety:
To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
Condition | Intervention | Phase |
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Meningococcal Meningitis Tetanus Diphtheria Pertussis Poliomyelitis |
Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 1024 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
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2: Experimental |
Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
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3: Experimental |
Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)
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Ages Eligible for Study: | 4 Years to 7 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Clinical Trials | sanofi pasteur |
Responsible Party: | Sanofi Pasteur Inc ( Medical Director ) |
Study ID Numbers: | MTA43 |
Study First Received: | July 20, 2006 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00355121 |
Health Authority: | United States: Food and Drug Administration |
Meningococcal meningitis Tetanus Diphtheria |
Pertussis Poliomyelitis Neisseria meningitidis |
Bacterial Infections Spinal Cord Diseases Meningitis, Meningococcal Whooping Cough Neisseria meningitidis Tetanus Whooping cough Gram-Negative Bacterial Infections Meningitis Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Neuromuscular Diseases Meningococcal Infections Motor Neuron Disease |
Neisseriaceae Infections Meningitis, Bacterial Cough Central Nervous System Diseases Picornaviridae Infections Degenerative motor system disease Diphtheria Motor neuron disease Meningococcal infection Virus Diseases Central Nervous System Infections Poliomyelitis Myelitis Enterovirus Infections Clostridium Infections |
Bordetella Infections RNA Virus Infections Corynebacterium Infections Nervous System Diseases |
Central Nervous System Bacterial Infections Central Nervous System Viral Diseases Infection Actinomycetales Infections |