NCT00841763

Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects

A Phase III, Randomized, Controlled, Observer-blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted With MF59 (Fluad-H5N1) in Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,647 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The present study, phase III, randomized, controlled, observer-blind, multicenter study, will evaluate safety, tolerability and immunogenicity of two doses of an adjuvanted monovalent influenza vaccine compared with an adjuvanted interpandemic trivalent influenza vaccine in a population of healthy adult and elderly subjects.

Conditions

• Pandemic Influenza Disease

Interventions

Type	Name	Description
BIOLOGICAL	Placebo (PL)	One dose of 0.5 ml IM injection of isotonic saline solution was administered in the deltoid muscle, preferably of the non-dominant arm.
BIOLOGICAL	Trivalent influenza virus vaccine (TIV)	A single IM injection of a 0.5 ml dose of non-adjuvanted trivalent influenza virus vaccine administered in the deltoid muscle, preferably of the non-dominant arm.
BIOLOGICAL	Adjuvanted monovalent influenza virus vaccine (aH5N1)	Two intramuscular (IM) injections of a 0.5 ml dose administered three weeks apart in the deltoid muscle.
BIOLOGICAL	Adjuvanted trivalent influenza virus vaccine (aTIV)	Two IM injections of a 0.5 ml dose of adjuvanted trivalent influenza virus vaccine administered three weeks apart, in the deltoid muscle.

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-04-01
• Completion: 2009-11-01
• First posted: 2009-02-11
• Last updated: 2021-04-23
• Results posted: 2013-01-18

Locations

2 sites across 2 countries: Finland, Germany