A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

Phase 4 Completed 7500 enrolled Seqirus

RandomizedParallel-groupTriple-blindPrevention

Summary

This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.

Timeline

Start: 2008-03
Primary completion: 2009-11
Completion: 2010-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); CSL's IVV vs Placebo; Vaccine Efficacy 42 (95% CI 30 to 52) NCT00562484 ↗

paper Vaccine efficacy of the 2008 and 2009 IIV3s against influenza due to any strain was 42% (95% confidence interval [CI]: 30%, 52%) PMID 27595443 ↗

Publications

Mcbride WJH, Abhayaratna WP, Barr I, Booy R, Carapetis J, Carson S, De Looze F, Ellis-Pegler R, Heron L, Karrasch J, Marshall H, Mcvernon J, Nolan T, Rawlinson W, Reid J, Richmond P, Shakib S, Basser RL, Hartel GF, Lai MH, Rockman S, Greenberg ME. Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial. Vaccine. 2016 Sep 22;34(41):4991-4997. doi: 10.1016/j.vaccine.2016.08.038. Epub 2016 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CSL Limited Influenza Vaccine	Vaccine	0.5 ml	Intramuscular