NCT00478816

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With Adjuvanted or Non-adjuvanted Influenza Vaccines

A Phase II, Single Center, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Adults Unprimed and Primed With MF59-adjuvanted or Non-adjuvanted H5N3 Influenza Vaccines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Valuate the immune response and reactogenicity of H5N1 vaccination in a primed population (H5N3 adjuvanted or non-adjuvanted vaccine) compared to immunologically naïve subjects

Conditions

• Prophylaxis of Avian Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Fluad H5N1 Pandemic Influenza Vaccine	Two 0.5 mL doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1 Clade 1) hemagglutinin (HA) subvirion influenza vaccine, containing 7.5 μg of H5N1 antigen,administered 3 weeks apart, IM in the deltoid muscle, preferably of the non-dominant arm.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-05-25
• Last updated: 2016-12-01

Locations

1 site across 1 country: United Kingdom