Status:
COMPLETED
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults
Lead Sponsor:
Sanofi
Conditions:
Influenza
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This multi-center study will be conducted in the United States with up to 80 healthy adult subjects. Subjects will be scheduled to receive a total of two (2) injections with 1 injection each administe...
Detailed Description
All subjects will be followed up for 60 days post-randomization and through the influenza season. Following the influenza season, a subset of the subjects will receive a booster vaccine at the 12 mont...
Eligibility Criteria
Inclusion
- Adult males or females 18 - 40 years of age in good general health
Exclusion
- Known allergies or severe reactions to any of the vaccine components including those to adjuvants
- History of severe allergic reactions, including angioedema;
- History of asthma or recurrent wheezing; (current or within past 2 years);
- History of neurological symptoms or signs following administration of any vaccine;
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00819013
Start Date
July 1 2007
End Date
February 1 2009
Last Update
January 19 2012
Active Locations (3)
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1
Miami Research Associates
Miami, Florida, United States, 33143
2
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
3
Northwest Kinetics
Tacoma, Washington, United States, 98418