NCT02107807

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditions *aH5N1:Monovalent H5N1 Influenza Vaccine

A Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1when Administered to Adult and Elderly Subjects With and Without Immunosuppressive Conditions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 539 (actual)
• Sponsor: Seqirus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate the safety, immune response and reactogenicity of aH5N1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.

Conditions

• Influenza, Human
• Flu, Human
• Flu, Avian
• Influenza
• Influenza A Virus, H5N1 Subtype

Interventions

Type	Name	Description
BIOLOGICAL	Novartis Investigational H5N1 vaccine	2 doses of 0.5 ml, 3 weeks apart
BIOLOGICAL	Novartis Investigational H5N1 vaccine	2 doses of 0.5 ml, 3 weeks apart
BIOLOGICAL	Novartis Seasonal Influenza Vaccine	2 doses of 0.5 ml, 3 weeks apart
BIOLOGICAL	Novartis Seasonal Influenza Vaccine	2 doses of 0.5 ml, 3 weeks apart

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-04-08
• Last updated: 2016-05-09

Locations

17 sites across 3 countries: Australia, Germany, Italy