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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00491985 |
Purpose
This is an open, randomized, multicenter clinical trial.
Objectives:
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Orthomyxoviridae Infections Influenza A Virus Infection |
Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 240 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Subjects aged 9 to 17 years
|
Biological: A/H5N1 Inactivated, split-virion pandemic influenza vaccine
0.5 mL, Intramuscular
|
|
2: Experimental
Subjects aged 3 to 8 years
|
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.5 mL, Intramuscular
|
|
3: Experimental
Subjects aged 6 to 35 months
|
Biological: A/H5N1 Inactivated, split virion pandemic influenza vaccine
0.25 mL, Intramuscular
|
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
Contacts and Locations
More Information
| Responsible Party: | Sanofi Pasteur Inc ( Medical Monitor ) |
| Study ID Numbers: | GPA04 |
| Study First Received: | June 26, 2007 |
| Last Updated: | September 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00491985 History of Changes |
| Health Authority: | Thailand: Food and Drug Administration |
|
Influenza A/H5N1 Virus Influenza Pandemic Orthomyxoviridae Infections |
|
Virus Diseases Communicable Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections Infection |