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.
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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 |
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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. |