NCT01897701

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

A Phase 1 Randomized, Observer-Blinded, Dose-Ranging Study to Evaluate the Immunogenicity and Safety of Monovalent A/Anhui/1/2013 (H7N9) Virus-Like Particle (VLP) Avian Influenza Antigen (Recombinant) in Healthy Adults With and Without Adjuvant 1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Novavax · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Avian Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Monovalent Avian Influenza VLP (H7N9)
BIOLOGICAL	Adjuvant 1
BIOLOGICAL	Placebo

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-07-12
• Last updated: 2014-10-13

Locations

3 sites across 1 country: Australia