NCT02839330

A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

A Phase 3 Randomized, Observer-Blind, Multi-center, Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,196 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This Phase 3 study evaluates the safety, immunogenicity and lot-to lot consistency of 3 lots of aH5N1c vaccine for pandemic avian influenza, in approximately 2394 healthy adults ≥18 years of age receiving the vaccine and 797 healthy adults receiving placebo. Subjects were randomized in a 3:1 ratio to receive either aH5N1c vaccine or saline placebo. Enrollment was stratified by age: 18 to \<65 years of age and ≥65 years of age, to allow adequate safety assessment of the entire age spectrum.

Conditions

• Avian Influenza

Interventions

Type	Name	Description
BIOLOGICAL	aH5N1c	Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).
BIOLOGICAL	Placebo	Placebo: Saline injection

Timeline

• Start date: 2016-07-11
• Primary completion: 2017-10-04
• Completion: 2017-10-04
• First posted: 2016-07-20
• Last updated: 2024-12-06
• Results posted: 2019-04-04

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study