NCT02091908

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Underlying Medical Conditions

Phase III, Stratified, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Doses of aH5N1 When Administered to Adult and Elderly Subjects With and Without Underlying Medical Conditions.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (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 underlying medical conditions.

Conditions

• Influenza, Human

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: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-03-19
• Last updated: 2016-11-04

Locations

6 sites across 1 country: Germany