A(H7N9) VLP Antigen Dose Ranging Study With Adjuvant 1

Summary

This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups. Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose.

Timeline

Start

2013-07

Primary completion

2014-08

Completion

2014-08

Publications

• Fries LF, Smith GE, Glenn GM. A recombinant viruslike particle influenza A (H7N9) vaccine. N Engl J Med. 2013 Dec 26;369(26):2564-6. doi: 10.1056/NEJMc1313186. Epub 2013 Nov 13. No abstract available.

Drugs

Indications