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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00259337 |
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.
Safety:
This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
Condition | Intervention | Phase |
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Diphtheria Tetanus Polio Pertussis Haemophilus Infections |
Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 226 |
Study Start Date: | February 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: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
0.5 mL, IM
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Ages Eligible for Study: | 42 Days to 56 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur Inc. ( Medical Director ) |
Study ID Numbers: | E2I41 |
Study First Received: | November 24, 2005 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00259337 |
Health Authority: | India: Indian Council of Medical Research |
Diphteria Tetanus Polio |
Acellular Pertussis Hib Haemophilus influenzae type B |
Haemophilus Infections Bacterial Infections Haemophilus influenzae Whooping Cough Cough Diphtheria Tetanus Whooping cough |
Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Influenza, Human Clostridium Infections |
Bordetella Infections Pasteurellaceae Infections Corynebacterium Infections Infection Actinomycetales Infections |