Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines

Phase 3 Completed 4902 enrolled Novartis Novartis Vaccines · collab

RandomizedParallel-groupSingle-blindPrevention

Summary

This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \<72 months of age.

Timeline

Start: 2007-11
Primary completion: 2010-04
Completion: 2010-08

Publications

Results Vesikari T, Knuf M, Wutzler P, Karvonen A, Kieninger-Baum D, Schmitt HJ, Baehner F, Borkowski A, Tsai TF, Clemens R. Oil-in-water emulsion adjuvant with influenza vaccine in young children. N Engl J Med. 2011 Oct 13;365(15):1406-16. doi: 10.1056/NEJMoa1010331.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluad	Vaccine	0.25 ml	Intramuscular
Subject	Fluad	Vaccine	0.5 ml	Intramuscular
Comparator	Menjugate	Vaccine	—	Intramuscular
Comparator	Non-adjuvanted trivalent inactivated split influenza vaccine	Vaccine	0.25 ml	Intramuscular
Comparator	Non-adjuvanted trivalent inactivated split influenza vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	Non-adjuvanted trivalent inactivated subunit influenza vaccine	Vaccine	0.25 ml	Intramuscular
Comparator	Non-adjuvanted trivalent inactivated subunit influenza vaccine	Vaccine	0.5 ml	Intramuscular
Comparator	Tick-Borne Encephalitis vaccine	Vaccine	—	Intramuscular

Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines

Summary

Timeline

Publications

Drugs

Indications