ab Reeve 1982.
Methods | Randomised controlled trial carried out in Wien | |
Participants | 20 university students aged 20 to 24 years | |
Interventions | 1st phase: cold‐recombinant, live flu vaccine II RB‐77 (B/Ann Arbor/1/66 and B/Tecumse/10/77) containing 107.2 EID50 per 0.5 mL dose versus placebo. 1 dose intranasally. During this phase, participants lived under sequestered condition, and close contact between vaccine and placebo recipients was possible. 2nd phase: 3 weeks after the 1st dose all participants were immunised with 1 dose of the same vaccine | |
Outcomes | During the 5 days following immunisation, participants were medically observed and temperature recorded morning and evening. Occurring symptoms were attributed scores (0 to 3) depending on their severity (no, light, moderate, severe). Fever (oral temperature > 38 °C): 0/10, 0/10; sneezing: 1/10, 0/10; stuffy nose: 7/10, 1/10; running nose: 3/10, 0/10; afebrile subjective symptoms: 8/10, 2/10 | |
Notes | Safety data only were extracted Industry 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 |