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 |
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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 |