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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00415129 |
Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (>60 years) as required by the EMEA guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.
Condition | Intervention | Phase |
---|---|---|
Influenza Orthomyxoviridae Infections |
Biological: A/H5N1 inactivated, split-virion influenza virus |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 600 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Vaccine with adjuvant
|
Biological: A/H5N1 inactivated, split-virion influenza virus
0.5mL, Intramuscular
|
2: Experimental
Vaccine without adjuvant
|
Biological: A/H5N1 inactivated, split-virion influenza virus
0.5mL, Intramuscular
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Responsible Party: | Sanofi Pasteur Inc. ( Medical Director ) |
Study ID Numbers: | GPA02 |
Study First Received: | December 21, 2006 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00415129 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Influenza Orthomyxoviridae Infections Influenza Pandemics A/H5N1 strain |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections |
RNA Virus Infections Infection |