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. 2012 Aug 15;2012(8):CD004879. doi: 10.1002/14651858.CD004879.pub4

cb Slepushkin 1994

Methods Cohort study to compare reactogenicity and immunogenicity in children vaccinated with live vaccine, inactivated vaccine or placebo carried out over 3 years in Novogorod, former USSR. No mention of randomisation is made and the study was classified as a cohort. Allocation was on a school basis. A subgroup was inoculated each year of study prior to mass inoculations to determine reactogenicity and immunogenicity. Reactogenicity and immunogenicity results were analysed using 'generally accepted methods' (Slepushkin et al 1991, Ibid, 5: 372‐4)
Participants Children aged 7 to 14 years
Interventions

  • 1989 ‐ Soviet Commercial bivalent‐vaccine A/Sichuan/2/87‐like (H3N2) and A/Taiwan/1/86‐like (H1N1) ‐ inactivated

  • 1989 ‐ Soviet Commercial bivalent ‐vaccine A/Sichuan/2/87‐like (H3N2) and A/Taiwan/1/86‐like (H1N1) ‐ live

  • 1990 ‐ A/Shanghai/11/87 (H3N2), A/Taiwan/1/86 (H1N1), B/Victoria/2/87 ‐ inactivated

  • 1990 ‐ A/Shanghai/11/87 (H3N2), A/Taiwan/1/86 (H1N1), B/Victoria/2/87 ‐ live

  • 1991 ‐ A/Shanghai/11/87 (H3N2), A/Taiwan/1/86 (H1N1), B/Victoria/2/87‐ inactivated

  • 1991 ‐ A/Shanghai/11/87 (H3N2), A/Taiwan/1/86 (H1N1), B/Yamogota/16/88‐like ‐ live


THERE IS NO PLACEBO ARM REPORTED IN THE THIRD YEAR, WHICH IS STRANGE AS THERE IS A PLACEBO ARM REPORTED FOR IMMUNOGENICITY IN TABLE 2. FOR THE SECOND YEAR THERE IS ALSO A MYSTERIOUS SECOND INACTIVATED VACCINE WHICH APPEARS IN THE RESULTS TABLES ‐ DATA NOT EXTRACTED To obtain live recombinant vaccine, cold‐adapted strains A/Leningrad/134/47/57 (H2N2) and B/USSR/60/69 were used as attenuation donors
Outcomes Serological Seroconversion (not extracted)
Effectiveness N/A
Safety Temperature reactions and local hyperemia and infiltration after vaccination
Funding Source Government
Notes The authors do not draw clear conclusions and it is difficult to understand what the purpose of the study was. Badly reported, no clear overall denominator and safety data is reported for limited groups of participants with no clear sampling rule
Risk of bias
Bias Authors' judgement Support for judgement
PCS/RCS‐Selection Exposed cohort Unclear risk No description
PCS/RCS‐Selection Non Exposed cohort Unclear risk No description
PCS/RCS‐Comparability Unclear risk No description
PCS/RCS‐Assessment of Oucome Unclear risk No description
Summary assessments High risk Insufficient information