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. 2012 Aug 15;2012(8):CD004879. doi: 10.1002/14651858.CD004879.pub4
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 needless injector or placebo. Placebo is not described
Outcomes Serological Paired sera taken in a non‐described fashion. There were antibody rises to other influenza A viruses and PIV 1 in the placebo arm
Effectiveness ILI 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