Study of the Safety and Immunogenicity of an Influenza Vaccine Administered to Healthy Adults

Phase 2 Completed 613 enrolled Novartis Vaccines Novartis Vaccines and Diagnostics (formerly Chiron Vaccines) · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of cell culture-derived, inactivated, subunit influenza vaccine in comparison to licensed Fluvirin vaccine administered to healthy adults ages 18 \< 50 years.

Timeline

Start: 2005-10
Primary completion: 2005-12
Completion: 2006-05

Outcome

Mixed primary results

registry Ratio of GMT 0.57 (95% CI 0.46 to 0.70); ANOVA NCT00264576 ↗

registry the lower limit of the 95% confidence interval (CI) around the ratio of the postvaccination GMTs had to be >0.5. NCT00264576 ↗

registry Ratio of GMT 0.92 (95% CI 0.76 to 1.12); ANCOVA NCT00264576 ↗

registry Ratio of GMT 0.69 (95% CI 0.57 to 0.83); ANCOVA NCT00264576 ↗

Publications

Results Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity. J Infect Dis. 2009 Sep 15;200(6):849-57. doi: 10.1086/605506.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CCIV	Vaccine	—	Other
Subject	Fluvirin®	Vaccine	—	Other