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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed), Compared to Infanrix®-IPV+Hib When Both Vaccines Are Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age |
| Enrollment: | 588 |
| Study Start Date: | July 2006 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
PEDIACEL co-administered with Prevenar
|
Biological: PEDIACEL® and Prevenar®
0.5 mL each, IM (opposite thigh)
Other Names:
|
|
Active Comparator: Group 2
Infanrix-IPV+Hib co-administered with Prevenar
|
Biological: Infanrix®-IPV+Hib and Prevenar®
0.5 mL each, IM (opposite thigh)
Other Names:
|
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: | Medical Monitor, Sanofi Pasteur, Inc. |
| ClinicalTrials.gov Identifier: | NCT00343421 History of Changes |
| Other Study ID Numbers: | A5I16 |
| Study First Received: | June 21, 2006 |
| Last Updated: | January 20, 2010 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; Poland: Ministry of Health |
|
Diphtheria Tetanus Pertussis |
Poliomyelitis Haemophilus influenzae type b Pneumococcal infections |
|
Diphtheria Haemophilus Infections Influenza, Human Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Bordetella Infections Infection Myelitis Central Nervous System Viral Diseases Enterovirus Infections Picornaviridae Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections |