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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00313911 |
To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and OPV after any of the three vaccinations at 2, 4, and 6 months of age for each subject.
To evaluate the overall safety in terms of:
Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial.
Immunogenicity:
To document the immune response to HB antigen of the three batches of the investigational DTaP-IPV-HB-PRP~T vaccine.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B Hepatitis B |
Biological: DTaP-IPV-HB-PRP~T Biological: Tritanrix-HepB/Hib |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 2133 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: DTaP-IPV-HB-PRP~T
0.5 mL, IM
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2: Active Comparator |
Biological: Tritanrix-HepB/Hib
0.5 mL, IM
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Ages Eligible for Study: | 50 Days to 71 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
Study ID Numbers: | A3L04 |
Study First Received: | April 11, 2006 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00313911 |
Health Authority: | Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Mexico: Ministry of Health |
Diphtheria Tetanus Pertussis Recombinant Hepatitis B |
Poliomyelitis Haemophilus influenzae type b Tetanus protein |
Bacterial Infections Liver Diseases Haemophilus influenzae Hepatitis, Viral, Human Whooping Cough Cough Orthomyxoviridae Infections Diphtheria Tetanus Whooping cough Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Hepatitis B Influenza, Human DNA Virus Infections Clostridium Infections |
Bordetella Infections RNA Virus Infections Corynebacterium Infections |
Infection Hepadnaviridae Infections Actinomycetales Infections |