NCT01766921

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Elderly Subjects.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,393 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in elderly subjects

Conditions

• Pandemic H5N1 Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted H5N1 pandemic influenza vaccine	Comparison of two doses of aH5N1c vaccine

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2013-01-11
• Last updated: 2019-01-30
• Results posted: 2015-08-10

Locations

23 sites across 4 countries: United States, Australia, New Zealand, Thailand