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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00255021 |
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Poliomyelitis Haemophilus Infections Pertussis |
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 186 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | June 2008 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM
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Ages Eligible for Study: | 2 Months to 2 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur, Inc ( Medical Director ) |
Study ID Numbers: | E2I34 |
Study First Received: | November 15, 2005 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00255021 |
Health Authority: | Thailand: Food and Drug Administration |
Diphteria Tetanus Pertussis |
Poliomyelitis Haemophilus influenzae type b acellular |
Bacterial Infections Haemophilus Infections Spinal Cord Diseases Whooping Cough Tetanus Whooping cough Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Neuromuscular Diseases Motor Neuron Disease Haemophilus influenzae |
Cough Picornaviridae Infections Central Nervous System Diseases Degenerative motor system disease Diphtheria Motor neuron disease Virus Diseases Central Nervous System Infections Poliomyelitis Influenza, Human Myelitis Enterovirus Infections Clostridium Infections |
Bordetella Infections Pasteurellaceae Infections RNA Virus Infections Corynebacterium Infections |
Nervous System Diseases Central Nervous System Viral Diseases Infection Actinomycetales Infections |