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 |
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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 |