Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

Phase 3 Completed 11404 enrolled Novartis Vaccines

RandomizedParallel-groupSingle-blindPrevention

Summary

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Timeline

Start: 2007-10
Primary completion: 2008-07
Completion: 2008-07

Outcome

Met primary endpoint

registry analysis (unspecified test); CCI Vaccine vs Placebo; p <0.001; Vaccine Efficacy 83.8 NCT00630331 ↗

registry analysis (unspecified test); IVV Vaccine vs Placebo; p = 0.004; Vaccine Efficacy 78.4 NCT00630331 ↗

Publications

Results Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S. Clinical efficacy of cell culture-derived and egg-derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis. 2010 Nov 1;51(9):997-1004. doi: 10.1086/656578.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cell culture derived influenza vaccine	Vaccine	0.5 ml	Intramuscular
Subject	Egg-derived influenza virus vaccine	Vaccine	0.5 ml	Intramuscular