ab Goodeve 1983.
Methods | Randomised controlled trial, double‐blind | |
Participants | 119 healthy young adults from the Medical and Science Faculties of Sheffield University, UK, aged 18 to 19 years without egg allergy | |
Interventions | Purified subunit monovalent B/Hong Kong/73 flu vaccine prepared in 4 antigen concentrations of 40, 20, 10, 5 µg of HA per each 0.5 mL dose versus saline placebo (0.5 mL dose) subcutaneously administered. Participants were divided into 5 groups of equal dimensions (no further description), each group received 1 of the tested coded preparations. Artificial challenge 1 month later with live attenuated RB77 virus. | |
Outcomes | Local and systemic reactions were assessed by means of questionnaires completed by participants 24 hours after immunisation. Local reactions (including redness, swelling, itching), local pain (including pain on pressure, pain on contact, continuous pain). | |
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 |