aa Weingarten 1988.
Methods | Randomised controlled trial, double‐blind, conducted in the USA during the 1985 to 1986 influenza season. Follow‐up was not indicated. Epidemic influenza was defined according to population surveillance data (without better explanation), begun in December 1985 and concluded in February 1986. Participants were assigned using a random number generator to receive either the influenza vaccine or placebo. Virological surveillance was not performed. | |
Participants | 179 healthy volunteer hospital employees: 91 treated and 88 placebo. Age of participants was 21 to 65. | |
Interventions | Split trivalent intramuscular vaccine. Schedule and dose were: single dose; 15 µg each strain. Vaccine composition was: A/Chile/1/83 (H1N1), A/Philippines/2/82 (H3N2), and B/USSR/100/83. Placebo was saline for injection. Vaccine was recommended but did not match the circulating strain. | |
Outcomes | Clinical cases symptoms defined, WDL regardless of cause, and adverse effects. Influenza illness was defined by the CDC case definition: a documented temperature greater than 100 °F and at least the symptoms of cough or sore throat. | |
Notes | Data regarding WDL and adverse effects were not complete and they were not considered. Most of the influenza infections were caused by type B.
Efficacy data only were extracted. Government funded. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Unclear |
Allocation concealment (selection bias) | Unclear risk | Unclear |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
Summary assessment | Unclear risk | Unclear |