aa Hammond 1978.
Methods | Controlled clinical trial, double‐blinded conducted in Australia during the 1976 influenza season. Follow‐up lasted the whole epidemic period. Epidemic influenza was defined by virus isolation and serology tests and lasted from middle of April to middle of August 1976 (17 weeks). Coded, identical‐looking vials were sequentially administered to enrolled participants. A throat swab was collected from ill people. Serological confirmation was performed on all participants. | |
Participants | 225 medical students or staff members: 116 treated and 109 placebo. Age of participants was not indicated. | |
Interventions | Trivalent parenteral subunit vaccine. Schedule and dose were: single dose; vaccine composition was: 250 IU of A/Victoria/3/75, 250 IU of A/Scotland/840/74, and 300 IU of B/Hong Kong/8/73. Placebo was diphtheria and tetanus toxoids. Vaccine was recommended and matched circulating strain. | |
Outcomes | Influenza‐like illness, influenza. Clinical illnesses were not defined. Influenza was defined as respiratory illness that was associated with the isolation of influenza virus, a 4‐fold or greater rise in antibody titre occurring between postvaccination and postepidemic sera, or both. Surveillance was active. | |
Notes | Clinical illness was not defined, and data were included in the analysis as "clinical cases without clear definition". Circulating strain was A/Vic/3/75‐like. 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) | High risk | Alternate |
Allocation concealment (selection bias) | High risk | No description |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No description |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No description |
Summary assessment | High risk | No description |