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

ab El'shina 1996.

Methods Randomised controlled trial
Participants 432 healthy participants aged between 18 and 22 years who had not received any influenza immunisation during the previous 2 to 3 years.
Interventions Polymer‐subunit influenza vaccine Grippol prepared with the strains A/Victoria/36/88, Wib ‐ 26, B/Panama 45/90. 2 types containing 5 or 2.5 µg haemagglutinin of each strain, respectively were compared with whole‐virion inactivated trivalent vaccine (reference preparation, containing 35 µg of haemagglutinin) and placebo (consisting of sterile physiological solution). One 0.5 mL dose was administered subcutaneously.
Outcomes After immunisation, participants were placed under medical observation. Fever (48 hours follow‐up): weak (37.1 to 37.5 °C), moderate (37.6 to 38.5 °C), severe (> 38.6 °C). Systemic reactions (3 to 4 days follow‐up): feeling unwell, sore throat, hyperaemia of nasopharynx, head cold, cough, headache, blocked nose, dizziness, shivering, drowsiness, nausea, hoarseness. Local reaction: all (moderate weak); pain at site of injection.
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