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Your journey
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More info
You can access this
clinical trial
if you have
Influenza
and you are
between 18 and 49
years old
1
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 270, 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 MF59 or diluent (N=216, up to 270). All eligible subjects will receive 2 doses separated by approximately 21 days.

Provided treatments

  • Other: Phosphate Buffered Saline (PBS) diluent
  • Drug: MF59 Adjuvant
  • Biological: 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: NCT01317745. The sponsor of the trial is National Institute of Allergy and Infectious Diseases (NIAID) and it is looking for 270 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 MF59 Adjuvant