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Your journey
1What's a trial
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More info
You can access this
clinical trial
if you have
and you are
between 18 and 49
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

Approximately 216, and up to 240, healthy males and non-pregnant females, 18 to 49 years old, inclusive, will be enrolled over a 5-month period into this multicenter, randomized, double-blinded, controlled Phase I study. Subjects who meet the entry criteria for the study and provide informed consent will be randomized 2:1 between adjuvanted and unadjuvanted vaccine and placed into one of 6 groups (see table) to receive two doses of an intramuscular subvirion inactivated monovalent influenza A/H5N1 virus vaccine at 3.75, 7.5, or 15 mcg given with the adjuvant AS03 or diluent (N=216, up to 240). All eligible subjects will receive 2 doses separated by approximately 21 days.

Provided treatments

  • Drug: AS03 Adjuvant
  • Other: Phosphate Buffered Saline (PBS) diluent
  • Biological: Sanofi H5N1 Antigen

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01317758. The sponsor of the trial is National Institute of Allergy and Infectious Diseases (NIAID) and it is looking for 245 volunteers for the current phase.
Official trial title:
A Randomized, Double-Blinded, Controlled, Phase I Study in Healthy Adults to Assess the Safety, Reactogenicity, and Immunogenicity of Intramuscular Subvirion Inactivated Monovalent Influenza A/H5N1 Virus Vaccine Administered at Different Dose Levels Given With and Without AS03 Adjuvant