ab Desheva 2002

Methods	RCT of adult variant (single‐dose) of live influenza vaccine in children aged 3 to 6 years. Two groups of children were formed to receive vaccine, 1 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 ‐ based on data from medical records which included 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 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) were 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 prevent 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