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

ca Vasil'eva 1982.

Methods Comparative cohort study of a monovalent injected vaccine in children aged 7 to 15 years in Leningrad, former USSR. The setting, season, and viral circulation are not described.
Participants 335 children of unknown provenance
Interventions Monovalent inactivated vaccine containing A/Texas/1/77 (H3N2) (Leningrad Louis Pasteur laboratories) subcutaneous or by needleless injector or placebo. Placebo is not described.
Outcomes Serological
 Paired sera taken in an undescribed fashion. There were antibody rises to other influenza A viruses and PIV 1 in the placebo arm.
Effectiveness
 Influenza‐like illness described in the translation as "influenza and URTI". Breakdown by age groups and type of injection is not reported.
Safety
 Temperature, induration, headache, malaise, sore throat. Daily physical examinations for 5 days.
Funding Source Unclear
Notes The authors conclude that the vaccine (incidence in the arms was 1.8 and 9.9, respectively) was effective, immunogenic, and safe. Very brief report. There is no description of randomisation, allocation, or attrition. The authors briefly described evidence of A/Khabarovsk/77, A/Texas/77, and PIV 1 circulation in the placebo arm, which could account for some of the febrile episodes.
Risk of bias
Bias Authors' judgement Support for judgement
PCS/RCS‐Selection Exposed cohort Unclear risk Not described
PCS/RCS‐Selection Non Exposed cohort Unclear risk Not described
PCS/RCS‐Comparability Unclear risk Not described
PCS/RCS‐Assessment of Oucome Unclear risk Not described
Summary assessments High risk Insufficient information to assess study design