ab Betts 1977a.
Methods | Randomised controlled trial carried out from April 1976 at Rochester University. Vaccine and placebo were randomly administered in a double‐blind manner, but no description of allocation procedure is given. 36 days after immunisation all participants were challenged with wild type virus (A/Victoria/3/75, H3N2), and antibody response was determined from serum and nasal secretions (before vaccination, 36 hours later, and 21 days after challenge, not for analysis). | |
Participants | 47 healthy male and female university students with absent or low HI titre (i.e. little or no immunity) to both A/Scotland/74 and A/Victoria/3/75. | |
Interventions | Live attenuated A/Scotland/74 (H3N2) versus placebo, one 0.5 mL dose intranasally. On day 37 after immunisation, participants were challenged with A/Victoria/3/75. | |
Outcomes | A physician examined the participants 1 day and 4 days after they received vaccine or placebo. Temperature was observed only 1 day after. Observed symptoms were: mild sore throat and rhinorrhoea: vaccine 4/23, placebo 3/24; fever (temperature > 37.50 °C): none had it. | |
Notes | Safety data only were extracted. Industry 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 | Not used |
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 |