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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00954798 |
The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
Condition | Intervention | Phase |
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Influenza Swine-origin A/H1N1 Influenza |
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly Subjects |
Estimated Enrollment: | 450 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A/H1N1 Vaccine Group 1: Experimental
Participants will receive A/H1N1 vaccine formulation 1
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Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and day 21
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A/H1N1 Vaccine Group 2: Experimental
Participants will receive A/H1N1 vaccine formulation 2
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Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and day 21
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A/H1N1 Vaccine Group 3: Experimental
Participants will receive A/H1N1 vaccine formulation 3
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Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
0.5 mL, Intramuscular on Day 0 and Day 21
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All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
France | |
Angers, France, 49000 | |
Tierce, France, 49125 | |
Laval, France, 53000 | |
Equeurdreville, France, 50120 | |
Cherbourg, France, 50100 | |
Chateau Gontier, France, 53200 |
Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | GPF07, UTN: U1111-1111-4918 |
Study First Received: | August 3, 2009 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00954798 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Influenza Pandemic Flu Swine-origin Influenza |
Inactivated split-virion vaccine Adjuvant Adult |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Adjuvants, Immunologic |
Influenza, Human Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |