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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00619502 |
This is a follow-up of Study A3L10. Immunogenicity
Safety
- To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.
Condition | Intervention | Phase |
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Diphtheria Polio Pertussis Hepatitis B |
Biological: DTaP-IPV-HB-PRP~T vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Enrollment: | 254 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: DTaP-IPV-HB-PRP~T vaccine
0.5 mL I.M
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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: | A3L22 |
Study First Received: | February 11, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00619502 |
Health Authority: | Turkey: Ministry of Health |
Hepatitis B Polio Diphtheria Pertussis H.influenzae type b |
Bacterial Infections Liver Diseases Haemophilus influenzae Hepatitis, Viral, Human Whooping Cough Cough Healthy Diphtheria 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 |
Bordetella Infections Corynebacterium Infections Infection Hepadnaviridae Infections Actinomycetales Infections |