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| Tracking Information | |||||
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| First Received Date ICMJE | March 31, 2006 | ||||
| Last Updated Date | October 9, 2008 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00309634 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged Between 18 and 60 Years | ||||
| Official Title ICMJE | Observer-Blind Monocentric Study in Adults Aged b/w 18-60 Yrs to Evaluate Reactogenicity and Immunogenicity of 1 and 2 Administrations of Pandemic Monovalent Influenza Vaccines Administered at Different Antigen Doses & Adjuvanted or Not. | ||||
| Brief Summary | Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus. The vaccines contain different antigen doses . For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Influenza | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00309634 | ||||
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | 106750 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | October 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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