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Sponsored by: |
Sanofi-Aventis |
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00258934 |
All marketed influenza vaccines are injected by the intramuscular (IM) route. This study will test whether an influenza vaccine is effective when injected by a route other than into the muscle. In order to prove this, the amount of antibodies in the blood will be measured before and after vaccination. In addition, the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination. The vaccine injected in this study is similar to the sponsor's marketed intramuscular influenza vaccine (Vaxigrip). In addition, the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions.
Primary Objective: To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes.
Secondary Objectives: To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency (EMEA) after the first injection.
Condition | Intervention | Phase |
Orthomyxoviridae Infections Influenza |
Biological: Inactivated, split-virion influenza vaccine Biological: Inactivated, split-virion, influenza virus |
Phase II |
MedlinePlus related topics: | Flu |
ChemIDplus related topics: | Influenza Vaccines Fluvirin |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 1000 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Biological: Inactivated, split-virion influenza vaccine
0.1 mL single annual dose
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2: Active Comparator |
Biological: Inactivated, split-virion, influenza virus
0.5 mL single annual dose
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Ages Eligible for Study: | 18 Years to 57 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
At Year 1 (Visit 05):
-Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 05
At Year 2 (Visit 07):
-Addendum to the informed consent form signed and dated by the subject prior to vaccination at Visit 07
Exclusion Criteria:
Related Info 
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Related Info 
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Responsible Party: | Sanofi Pasteur, Inc ( Medical Monitor ) |
Study ID Numbers: | GID15 |
First Received: | November 24, 2005 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00258934 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines; Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic |
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