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. 2018 Feb 1;2018(2):CD004879. doi: 10.1002/14651858.CD004879.pub5

aa Rudenko 1996b.

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
  • Cases of influenza and ARI

  • Safety: 18 categories of somatic illnesses up to 6 months after inoculation

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