| 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 |
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| 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 |