Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza

In brief

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 administered. Subjects will be randomized according to a randomization scheme.

Key facts

Study ID

NCT00819013

Run by

Sanofi

People needed

87

Starts

2007-07-01

Expected to finish

2009-02-01

Last updated by the study team

2012-01-19

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult males or females 18 - 40 years of age in good general health

You may not qualify if…

• 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;

Where it is running

• Miami Research Associates — Miami, Florida, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• Northwest Kinetics — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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