aa Nichol 1995.
Methods | Randomised controlled trial conducted in the USA during the 1994 to 1995 influenza season. Follow‐up lasted from 1 December 1994 through to 31 March 1995. Influenza period was not defined. Virological surveillance was not performed. | |
Participants | 841 full‐time employed: 419 treated and 422 placebo. Age of participants was 18 to 64. | |
Interventions | Subvirion, trivalent, parenteral influenza A and B vaccine. Schedule and dose were: single dose; 15 µg each strain. Vaccine composition was: A/Texas/36/91, A/Shangdong/9/93, B/Panama/45/90. Placebo was vaccine diluent. Vaccine was recommended and matched circulating strain. | |
Outcomes | Cases (symptom‐defined), working days lost due to respiratory illness, side effects. Participants were defined as cases if they had at least 1 upper respiratory illness (a sore throat associated with either fever or cough that lasted at least 24 hours). Local adverse effects were defined as arm soreness. Systemic adverse effects were defined as fever, tiredness, "feeling under the weather", muscle ache, headache (within a week after vaccination). Surveillance was active. | |
Notes | Circulating strain was not indicated. Efficacy and safety data were extracted. Industry funded |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed according to a computer‐generated randomisation schedule. |
Allocation concealment (selection bias) | Low risk | Probably adequate |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blinding was ensured by preloaded, coded, identical‐looking syringes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Adequate |
Summary assessment | Low risk | Adequate |