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

ab Desheva 2002.

Methods RCT of adult variant (single‐dose) of live influenza vaccine in children aged 3 to 6 years. 2 groups of children were formed to receive vaccine, 1 group to receive placebo. Paediatricians from clinics serving nurseries selected children for immunisation. Parental consent was obtained for each child. Medical examination of children was carried out each day for 5 days after inoculation: body temperature measured, local and general reactions recorded.
  • Re‐isolates obtained from vaccinated children 3 days after inoculation to determine genetic stability of viruses using PCR restriction analysis.

  • Morbidity was studied for 6 months after inoculation, which was based on data from medical records including influenza and acute respiratory illnesses and registration of somatic and infectious diseases.

Participants Children aged 3 to 6 years from nursery schools in the St Petersburg, Russia area
Interventions Trivalent, live influenza vaccine contained WHO recommended strains for 1999 to 2000: A/17/Peking/95/25 (H1N1), A/17/Sydney/97/76 (H3N2), and B/60/St‐Petersburg/95/20. Vaccine or placebo (allantoic fluid from chicken embryos) was administered once intranasally using RDZH‐M4 sprayer (0.25 mL per nostril). The difference between children and adult vaccines is the number of times passed at lower temperature and in the number of mutations of the base attenuated donor strains A(H1N1) and A(H3N2).
Outcomes Serological
 Paired serum samples were taken from subgroup prior to inoculation and 21 days after and analysed for haemagglutinin inhibition.
Effectiveness
 ILI, bronchitis infections, somatic illness, and allergic pathologies (the last 2 are difficult to understand and have not been extracted)
Safety
 Fever (in different temperature breakdowns), headache, and catarrhal symptoms
Funding Source Government
Notes The authors conclude that the vaccine is safe and effective. We do not think the data support this conclusion, as for example the vaccine does not protect against bronchitis. No viral circulation in community is described.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description
Allocation concealment (selection bias) Low risk Coded preparations
Blinding (performance bias and detection bias) 
 All outcomes Low risk Double‐blinding
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No losses to follow‐up
Summary assessments Low risk Plausible bias unlikely to seriously alter the results.