Safety and Immunogenicity of Three Dosage Levels of Swine Influenza Vaccine in Children Ages 3 to <9 Years, Adolescents 9 to <18 Years, Adults 18 to <65 Years and Elderly 65 Years and Older.

Phase 1 Completed 627 enrolled Novartis Vaccines

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Evaluate the safety and immunogenicity of three dosage levels of swine influenza vaccine in children ages 3 to \<9 years, adolescents 9 to \<18 years, adults 18 to \<65 years and elderly 65 years and older.

Timeline

Start: 2013-05
Primary completion: 2014-09
Completion: 2014-09

Publications

Johnson C, Hohenboken M, Poling T, Jaehnig P, Kanesa-Thasan N. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study. J Infect Dis. 2015 Jul 1;212(1):72-80. doi: 10.1093/infdis/jiu826. Epub 2014 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Swine Influenza	Vaccine	3.75 ug	—
Subject	Swine Influenza	Vaccine	7.5 ug	—
Subject	Swine Influenza	Vaccine	15 ug	—

Indications

No indication recorded.