A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years. (CSL's IVV)

NCT00562484 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Seqirus
Phase	Phase 4
Status	COMPLETED
Enrolment	7500
Start date	2008-03
Completion	2010-01

Conditions

• Influenza

Interventions

• CSL Limited Influenza Vaccine
• Placebo

Primary outcomes

• CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection — 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
  Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.

Countries

Australia, New Zealand