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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00654901 |
This is a follow-up of Study A3L11. Immunogenicity
Safety
- To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP-T.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Hepatitis B Poliomyelitis Haemophilus Influenzae Type B |
Biological: DTaP-IPV-HB-PRP~T vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 1199 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL, IM
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Ages Eligible for Study: | 15 Months to 18 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
Study ID Numbers: | A3L21, A3L21 |
Study First Received: | April 3, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00654901 |
Health Authority: | Mexico: Ministry of Health |
Diphtheria Tetanus Pertussis |
Hepatitis B Poliomyelitis Invasive Haemophilus influenzae type b. |
Bacterial Infections Liver Diseases Spinal Cord Diseases Whooping Cough Hepatitis, Viral, Human Orthomyxoviridae Infections Tetanus Whooping cough Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Hepatitis B Motor Neuron Disease |
Haemophilus influenzae Cough Picornaviridae Infections Central Nervous System Diseases Degenerative motor system disease Diphtheria Motor neuron disease Hepatitis Virus Diseases Digestive System Diseases Central Nervous System Infections Poliomyelitis Influenza, Human DNA Virus Infections Myelitis |
Bordetella Infections RNA Virus Infections Corynebacterium Infections Nervous System Diseases |
Central Nervous System Viral Diseases Infection Hepadnaviridae Infections Actinomycetales Infections |