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

NCT00492063 ↗

Phase 3 Completed 2654 enrolled Novartis Vaccines

RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start: 2004-09
Primary completion: 2004-12
Completion: 2005-05

Outcome

Met primary endpoint

paper The immunogenicity of CCIV was noninferior to that of the conventional vaccine for all 3 vaccine strains in both age groups, regardless of underlying health status. PMID 19673651 ↗

Publications

Results Szymczakiewicz-Multanowska A, Groth N, Bugarini R, Lattanzi M, Casula D, Hilbert A, Tsai T, Podda A. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis. 2009 Sep 15;200(6):841-8. doi: 10.1086/605505.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cell culture-derived trivalent subunit influenza vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	Egg-Derived Trivalent Subunit Influenza Vaccine	Vaccine	0.5 ml	Intramuscular