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. 2018 Feb 1;2018(2):CD001269. doi: 10.1002/14651858.CD001269.pub6

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”
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
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