NCT00306527

Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before in the V58P4 Study.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,235 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cell culture derived influenza vaccine	as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm
BIOLOGICAL	egg-derived influenza subunit vaccine	as a single IM injection of 0.5 ml in the deltoid muscle, preferably of the non-dominant arm

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-12-01
• Completion: 2006-04-01
• First posted: 2006-03-24
• Last updated: 2019-08-14
• Results posted: 2013-01-11

Locations

5 sites across 1 country: Poland