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| Tracking Information | |||||
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| First Received Date ICMJE | June 21, 2006 | ||||
| Last Updated Date | April 7, 2008 | ||||
| Start Date ICMJE | July 2006 | ||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: 1 month post-vaccination ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00343421 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib [ Time Frame: Entire study ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers | ||||
| Official Title ICMJE | |||||
| Brief Summary | 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:
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 560 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 55 Days to 75 Days | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France, Poland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00343421 | ||||
| Responsible Party | Medical Monitor, Sanofi Pasteur, Inc. | ||||
| Study ID Numbers ICMJE | A5I16 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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