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| Tracking Information | |||||
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| First Received Date ICMJE | June 26, 2007 | ||||
| Last Updated Date | September 22, 2008 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To describe safety following administration of A/H5N1 inactivated split virion pandemic influenza vaccine. [ Time Frame: 21 Days post-vaccination ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00491985 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Immunogenicity of 2 Formulations of an Intramuscular A/H5N1 Pandemic Influenza Vaccine in Children | ||||
| Official Title ICMJE | |||||
| Brief Summary | This is an open, randomized, multicenter clinical trial. Objectives:
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | Chotpitayasunondh T, Thisyakorn U, Pancharoen C, Pepin S, Nougarede N. Safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza A/H5N1 vaccine in children. PLoS ONE. 2008;3(12):e4028. Epub 2008 Dec 29. | ||||
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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 | 240 | ||||
| Estimated Completion Date | March 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria : All subjects:
Children/Adolescents aged >= 2 years to < 18 years:
Infants/toddlers aged >= 6 months to < 2 years:
Exclusion Criteria : All subjects:
Children/Adolescents aged >= 2 years to < 18 years:
Infants/toddlers aged >= 6 months to < 2 years:
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| Gender | Both | ||||
| Ages | 6 Months to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Thailand | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00491985 | ||||
| Responsible Party | Medical Monitor, Sanofi Pasteur Inc | ||||
| Study ID Numbers ICMJE | GPA04 | ||||
| Study Sponsor ICMJE | Sanofi-Aventis | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Sanofi-Aventis | ||||
| Verification Date | September 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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