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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00662870 |
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
Stage II Primary Objectives:
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Whooping Cough Polio Haemophilus Influenzae Type B |
Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) Biological: DTaP-IPV/Hib |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 1941 |
Study Start Date: | May 2001 |
Study Completion Date: | January 2004 |
Primary Completion Date: | January 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lot 1
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Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, IM
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2: Experimental
Lot 2
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Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, IM
|
3: Experimental
Lot 3
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Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)
0.5 mL, IM
|
4: Active Comparator |
Biological: DTaP-IPV/Hib
0.5 mL, IM
|
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Ages Eligible for Study: | 42 Days to 84 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Study Director: | Medical Monitor | Sanofi Pasteur, Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | P3T06 |
Study First Received: | April 17, 2008 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00662870 |
Health Authority: | United States: Food and Drug Administration |
DAPTACEL Diphtheria Tetanus Whooping Cough |
Polio Haemophilus influenzae type b Pertussis |
Bacterial Infections Haemophilus influenzae Whooping Cough Cough Diphtheria Orthomyxoviridae Infections Tetanus Whooping cough |
Gram-Negative Bacterial Infections Virus Diseases Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Influenza, Human Clostridium Infections |
Bordetella Infections RNA Virus Infections Corynebacterium Infections Infection Actinomycetales Infections |