ab Evans 1976.
Methods | Randomised controlled trial | |
Participants | 162 healthy participants aged 18 to 61 years | |
Interventions | Bivalent live attenuated vaccine WRL 105 (recombinant of A/Okuda/57 and A/Finland/4/74) containing 107.0 EID50 virus/0.5 mL dose versus placebo. Both preparations were administered intranasally 3 to 4 weeks apart. | |
Outcomes | Reactions to immunisation were observed for 7 days after each dose. Local symptoms (referable to the upper respiratory tract, mainly nasal obstruction, nasal discharge, or sore throat) reported as mild, moderate, or severe. General symptoms (mainly headache, fever, or myalgia). Local and general symptoms are further reported in different intensity classes (mild, moderate, severe, lasting for at least 4 days) reported as mild, moderate, or severe. Use of analgesics. | |
Notes | Safety data only were extracted. Funding source ‐ mixed |
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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 |