ab Pyrhönen 1981.
Methods | Randomised controlled trial conducted in the 1976 to 1977 season in Finland | |
Participants | 307 healthy adults | |
Interventions | 1 of the following 4 preparations was administered to 1 of the 4 study arms. “Volunteers were inoculated with bivalent subunit influenza vaccine containing 1200 IU of strain A/Victoria/3/75 (H3N2) antigen and 800 IU of B/Hongkong/8/73 antigen in 0.5 ml of phosphate or phosphate‐buffered saline solution as placebo” |
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Outcomes | Harms assessed by questionnaires filled out by each participant within 3 days after immunisation. Fever: vaccine 11/151, placebo 9/154; muscle ache: vaccine 26/151, placebo 12/154; redness: vaccine 53/151, placebo 3/154; tenderness at vaccination site: vaccine 89/151, placebo 12/154; tenderness of axillary glands: vaccine 6/151, placebo 2/154 | |
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) | 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 |