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| Sponsored by: |
Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00343421 |
Purpose
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
Primary Objectives:
Secondary Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Poliomyelitis Haemophilus Influenzae Type B |
Biological: PEDIACEL® and Prevenar® Biological: Infanrix®-IPV+Hib and Prevenar® |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 560 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: PEDIACEL® and Prevenar®
0.5 mL each, IM (opposite thigh)
|
| 2: Active Comparator |
Biological: Infanrix®-IPV+Hib and Prevenar®
0.5 mL each, IM (opposite thigh)
|
Eligibility| Ages Eligible for Study: | 55 Days to 75 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
| Study ID Numbers: | A5I16 |
| Study First Received: | June 21, 2006 |
| Last Updated: | April 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00343421 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Poland: Ministry of Health |
|
Diphtheria Tetanus Pertussis |
Poliomyelitis Haemophilus influenzae type b Pneumococcal infections |
|
Bacterial Infections Spinal Cord Diseases Whooping Cough Orthomyxoviridae Infections Tetanus Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Neuromuscular Diseases Motor Neuron Disease Degenerative Motor System Disease Haemophilus Influenzae |
Cough Picornaviridae Infections Central Nervous System Diseases Diphtheria Pneumococcal Infections Virus Diseases Central Nervous System Infections Poliomyelitis Influenza, Human Myelitis Enterovirus Infections Clostridium Infections |
|
Bacterial Infections Spinal Cord Diseases Whooping Cough Central Nervous System Viral Diseases Orthomyxoviridae Infections Infection Tetanus Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Neuromuscular Diseases Respiratory Tract Diseases Respiratory Tract Infections Corynebacterium Infections Motor Neuron Disease |
RNA Virus Infections Nervous System Diseases Picornaviridae Infections Central Nervous System Diseases Diphtheria Actinomycetales Infections Bordetella Infections Virus Diseases Central Nervous System Infections Poliomyelitis Influenza, Human Myelitis Enterovirus Infections Clostridium Infections |