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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00303316 |
This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV, pertussis or Hib vaccines and also to assess the quality of the induced immune memory in response to a booster dose of the same vaccine as in the primary series.
Primary Objective:
To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.
Secondary objective:
To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.
Condition | Intervention | Phase |
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Diphtheria Tetanus Pertussis Poliomyelitis Hepatitis B |
Biological: DTaP-IPV-HB-PRP~T combined vaccine Biological: DTaP-IPV//PRP~T combined vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 459 |
Study Start Date: | February 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: DTaP-IPV-HB-PRP~T combined vaccine
0.5 mL, IM
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2: Active Comparator
Received ENGERIX B® PEDIATRICO in Study A3L02
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Biological: DTaP-IPV//PRP~T combined vaccine
0.5 mL, IM
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Ages Eligible for Study: | 510 Days to 578 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
Study ID Numbers: | A3L16 |
Study First Received: | March 13, 2006 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00303316 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Diphtheria Tetanus Pertussis whooping cough |
Haemophilus influenzae type b Hepatitis B Poliomyelitis |
Bacterial Infections Liver Diseases Spinal Cord Diseases Whooping Cough Hepatitis, Viral, Human Healthy Tetanus Whooping cough Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Hepatitis B Motor Neuron Disease |
Immunoglobulins Haemophilus influenzae Cough Picornaviridae Infections Central Nervous System Diseases Degenerative motor system disease Diphtheria Motor neuron disease Hepatitis Virus Diseases Antibodies Digestive System Diseases Central Nervous System Infections Poliomyelitis Influenza, Human |
Bordetella Infections RNA Virus Infections Corynebacterium Infections Nervous System Diseases |
Central Nervous System Viral Diseases Infection Hepadnaviridae Infections Actinomycetales Infections |