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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 |
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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 History of Changes |
Health Authority: | Thailand: Food and Drug Administration |
Diphteria Tetanus Pertussis |
Poliomyelitis Haemophilus influenzae type b acellular |
Haemophilus Infections Bacterial Infections Spinal Cord Diseases Haemophilus Influenzae Central Nervous System Diseases Picornaviridae Infections Whooping Cough Cough Diphtheria Tetanus Gram-Negative Bacterial Infections Virus Diseases |
Gram-Positive Bacterial Infections Neuromuscular Diseases Central Nervous System Infections Respiratory Tract Infections Respiratory Tract Diseases Poliomyelitis Influenza, Human Myelitis Enterovirus Infections Clostridium Infections Degenerative Motor System Disease Motor Neuron Disease |
Bacterial Infections Haemophilus Infections Spinal Cord Diseases Whooping Cough Central Nervous System Viral Diseases Tetanus Infection Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Corynebacterium Infections Motor Neuron Disease |
Pasteurellaceae Infections RNA Virus Infections Nervous System Diseases Picornaviridae Infections Central Nervous System Diseases Diphtheria Actinomycetales Infections Bordetella Infections Virus Diseases Central Nervous System Infections Poliomyelitis Myelitis Enterovirus Infections Clostridium Infections |