Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

Phase 3 Completed 1200 enrolled Novartis Vaccines

RandomizedParallel-groupSingle-blindPrevention

Summary

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Timeline

Start: 2005-09
Primary completion: 2005-10
Completion: 2006-04

Outcome

Met primary endpoint

paper Lot-to-lot consistency was statistically demonstrated through bioequivalence for immunogenicity. PMID 19666152 ↗

Publications

Results Ambrozaitis A, Groth N, Bugarini R, Sparacio V, Podda A, Lattanzi M. A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009 Oct 9;27(43):6022-9. doi: 10.1016/j.vaccine.2009.07.083. Epub 2009 Aug 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cell-Derived Trivalent Subunit Influenza Vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	Egg-Derived Trivalent Subunit Influenza Vaccine	Vaccine	0.5 ml	Intramuscular