NCT00492063

Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly

A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,654 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cell culture-derived trivalent subunit influenza vaccine (cTIV)	One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
BIOLOGICAL	Egg-derived trivalent subunit influenza vaccine (TIV)	One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle

Timeline

• Start date: 2004-09-01
• Primary completion: 2004-12-01
• Completion: 2005-05-01
• First posted: 2007-06-27
• Last updated: 2016-01-01
• Results posted: 2013-02-21

Locations

5 sites across 1 country: Poland