Methods |
See aa Jackson 2010a (the following data refer to the second study season) |
Participants |
In season II (2006 to 2007), 4144 participants were recruited at 44 centres from 16 October 2006 onwards. |
Interventions |
Recruited participants were randomised at the beginning of each season to receive 1 dose of trivalent inactivated split influenza vaccine (FluLaval, a trademark of the GlaxoSmithKline group of companies; manufactured by ID Biomedical Corporation of Quebec, Canada) or saline placebo injection.
Each 0.5 mL dose of TIV contained 15 μg of haemagglutinin antigen of each recommended influenza strain
Antigens for season II (2006 to 2007) were:
A/New Caledonia/20/1999 (H1N1) virus
A/Wisconsin/67/2005 (H3N2)
B/Malaysia/2506/2004 |
Outcomes |
See aa Jackson 2010a |
Notes |
See aa Jackson 2010a |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
See aa Jackson 2010a |
Allocation concealment (selection bias) |
Unclear risk |
See aa Jackson 2010a |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
See aa Jackson 2010a |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
See aa Jackson 2010a |
Summary assessment |
Unclear risk |
See aa Jackson 2010a |