aa Eddy 1970.
Methods | Controlled clinical trial, single‐blind, conducted in South Africa during the 1969 influenza season. Follow‐up lasted from May to July. The first clinical case of influenza appeared on 21 May 1969 and the last 6 weeks later. The epidemic period lasted 6 weeks. The control participants were selected by drawing a 1‐in‐4 systematic sample from a ranked list of the personnel numbers. | |
Participants | 1758 healthy male black African employees: 1254 treated and 413 placebo. Age of participants was 18 to 65. | |
Interventions | Monovalent inactivated parenteral vaccine. Schedule and dose were single injection, 1 mL. Vaccine composition was: A2/Aichi/2/68 (Hong Kong variant). Placebo was sterile water. Vaccine was recommended and matched circulating strain. | |
Outcomes | Influenza‐like illness, working days lost, days ill. Influenza‐like illness was not defined; case features were generically described in results section. All ill people were admitted to hospital until recovery. Surveillance was passive. | |
Notes | The word 'double‐blinding' was not used, but the control group received an injection of "dummy vaccine". Poor reporting, poor‐quality study. Circulating strain was A2/Hong Kong/68 virus.
Efficacy data only were extracted. Industry funded |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Systematic selection |
Allocation concealment (selection bias) | High risk | Inadequate |
Blinding (performance bias and detection bias) All outcomes | High risk | No descriptions |
Incomplete outcome data (attrition bias) All outcomes | High risk | Insufficient description |
Summary assessment | High risk | High risk of bias |