Methods |
Cluster‐RCT
Inoculation of children from 16 schools and children's establishments, control groups from 14 schools and 20 preschool children's establishments
Children observed during vaccination period 6 November to 16 November 1986; rise in epidemic 17 November to 21 December 1986 and postepidemic period 22 December 1986 to 5 April 1987 and number of illnesses recorded
Vaccine administered intranasally using a Smirnov measured sprayer
Efficacy of vaccine assessed by comparing number of cases of influenza and ARI in vaccinated and UV groups and calculating index of efficacy using "generally accepted methods"
|
Participants |
Children aged 3 to 14 years |
Interventions |
Live recombinant vaccine made from 2 mono vaccines containing A/47/25/1 (H1N1) and A/47/F (H3N2) |
Outcomes |
|
Funding Source |
Unclear |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Insufficient description |
Allocation concealment (selection bias) |
High risk |
Not used |
Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
No blinding |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
No description |
Summary assessments |
High risk |
Insufficient information to assess study design |