ab Forsyth 1967.
Methods | From this report, only the first phase of the first trial is of interest to this review, in which administration of whole‐virus, oil adjuvanted influenza vaccine Invirin (GSK) was compared with placebo in a semi‐randomised allocation. The trial was performed November to December 1962. | |
Participants | Medical students (n = 380) at the Queen's University of Belfast, UK | |
Interventions | Trivalent aqueous vaccine (Invirin) one 0.25 mL dose IM containing strains A/Singapore/1/57, A/England/1/61, B/England/939/59. Placebo (phosphate‐buffered saline) was administered as control. Participants born on odd days were given placebo (n = 186); those born on even days received the vaccine (n = 194). | |
Outcomes | Local reactions: pain, erythema, tenderness, bruises. Stratified by means of scores ranging from 0 to 3 depending on their severity. Systemic reactions: coryza, migraine, paroxysmal tachycardia. All assessed at days 0, 1, 3, 7, 21 after inoculation. Data refer to a 3‐day follow‐up. | |
Notes | Safety 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 | Not used |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unclear |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear |
Summary assessment | High risk | Unclear |