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. 2018 Feb 1;2018(2):CD001269. doi: 10.1002/14651858.CD001269.pub6

aa Mixéu 2002.

Methods Randomised controlled trial, double‐blind, conducted in Brazil during the 1997 influenza season. Follow‐up lasted 6 to 7 months. Influenza period was not defined. Virologic surveillance was not performed.
Participants 813 flight crews of an airline company: 405 vaccinated and 408 given placebo. Age of participants was 18 to 64.
Interventions Split trivalent, intramuscularly administered vaccine. Schedule and dose were: single dose. Vaccine composition was: A/Nanchang/933/95, A/Texas/36/91, and B/Harbin/7/94. Placebo was vaccine diluent. Vaccine was recommended and matched circulating strain.
Outcomes ILI, WDL. Clinical illness was defined as follows: fever > 37.6 °C and cough, headache, myalgia, rhinorrhoea, sore throat lasting at least 24 hours. Surveillance was passive.
Notes Local and systemic effects were reported together and therefore not included in the review. Only 294 treated participants and 299 controls completed follow‐up. Efficacy data were extracted.
Industry funded
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors did not describe the methods used to ensure randomisation.
Allocation concealment (selection bias) Unclear risk Authors did not describe the methods used to ensure randomisation.
Blinding (performance bias and detection bias) 
 All outcomes Unclear risk Authors did not describe the methods used to ensure blinding.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low rates of attrition unlikely to affect study results.
Summary assessment Unclear risk Unclear