ab Hrabar 1977.
Methods | Randomised controlled trial, double‐blind, carried out during the season 1976 to 1977 | |
Participants | 167 students at the technical school in Zagreb, former Republic of Yugoslavia, without sensitivity to egg proteins, pregnancy, acute or chronic diseases | |
Interventions | Cold‐adapted recombinant A/Victoria/3/75 vaccine administered in 3 different antigen concentrations (107.5, 106.5, 105.5 EID50/0.5 mL) versus placebo. One 0.5 mL dose intranasally. | |
Outcomes | Participants were medically examined on each of the successive 5 days after immunisation (lasting for at least 1 day). Throat infection, granular palate, oedematous uvula, fever (no cases) as cases and subject‐days. For the following outcomes, authors give the total number of observed cases, without indication of the corresponding arm: malaise, swollen tonsils, fever (1), rhinorrhoea (1), conjunctivitis (7), laryngitis or hoarseness (3), cough (1), swollen tonsils (1), malaise (1). Surveillance was active. | |
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 |