ab Keitel 1993a.
Methods | "The two trials (Keitel 1993a and Keitel 1993b) tested three live attenuated vaccines." This paper reports the results of 2 randomised controlled trials carried out in the USA | |
Participants | Healthy volunteers recruited at Texas A&M University and Texas Medical Center, aged between 18 and 40 years | |
Interventions | Two 0.5 mL doses of cold‐adapted recombinant influenza vaccines, 1 month apart, containing 107.1 TCID50 of each strain/dose. 2 studies were conducted in which 4 groups were formed (2 interventions, 2 placebos): 1) placebo 1st and 2nd dose. 2) 1st: A/Kawasaki/9/86 (H1N1, CR 125) + A/Bethesda/1/85 (H3N2, CR90) + B/Ann Arbor/1/86 (B, CRB117) | |
Outcomes | Mild upper respiratory symptoms. Fever >= 37.8 °C within 1 week after each inoculation | |
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 |