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

ca Burtseva 1991

Methods Prospective cohort study of efficacy of live recombinant and inactivated influenza A (H3N2) vaccines versus placebo‐cold‐adapted recombinant live influenza vaccine A/47/F (H3N2) obtained by method described in other papers (Medvedeva et al, 1989. Vopr. Virusol.; 34: 564‐8 and Alexandrova et al. 1984. Infect. Immun.; 44: 734‐9)

  • Virus A/Philippines/2/82 (H3N2) used as epidemiological strain

  • Doctors notes collected from children absent in school 1 between 1/1/88 and 1/3/88 to find diagnoses of acute respiratory illness or influenza

  • Blood samples taken from recovering children in school 1

  • Blood samples taken from all children under observation before epidemic in January 1988 and 2 months after end of epidemic in April, 1988

  • Blood serum tested for inhibition of haemagglutinin for seroconversion to A/Philippines/2/82 (H3N2) and B/Victoria/2/87 (H1N1)

  • Children in school 1 re‐immunised in autumn 1988 with live influenza vaccine A/47/S produced by hybridisation of between cold‐adapted donor virus A/Leningrad/134/47/57 (H2N2) and a new drift variant of influenza A (H3N2) A/Sichuan/2/87

  • 4 groups of children received the following interventions: 1 ‐ live vaccine both years; 2 ‐ inactivated vaccine in year 1 and live vaccine in year 2; 3 ‐ placebo year 1 and live vaccine year 2; 4 placebo both years

  • Nasopharyngeal swabs taken from 41 children in various groups at 2, 3 and 8 days after vaccination, inoculated into chicken embryos and tested for hemagglutination. If no hemagglutination observed in on first test, was repeated at least 3 times. Antigenic structure of surface glycoproteins was defined in isolated strains

  • Paired serum samples taken from children revaccinated with A/47/S (H3N2) and tested for hemagglutination with antigens A/47/S (H3N2), A/Philippines/2/82 (H3N2), A/Taiwan/1/86 (H1N1) and B/Victoria/2/87

  • School 1 ‐ outbreak of influenza B (B/Victoria/2/87) occurred Dec 87 ‐ Jan 88 and influenza A (H3N2, close to A/Sichuan/2/87) occurred Jan to Feb 88. Determined by 4‐fold increase in antibodies from sub‐samples of children tested

  • School 2 ‐ epidemiological rise in from 3rd week January then continued until 3rd week Feb, 89% of confirmed influenza cases were A (H3N2) and only 11% were B
Participants Children aged 8 to 15 years
Interventions

  1. Cold‐adapted recombinant live influenza vaccine A/47/F (H3N2) ‐ infectious titre 7.0 1 EID50/0.2cc ‐ administered intranasally using Smirnov apparatus

  2. Inactivated influenza vaccine containing strains similar to A/Philippines/2/82 (H3N2) and A/Chile/1/83 (H1N1) containing 10 μg of haemagglutinin of each strain in 0.5 ml dose ‐ administered subcutaneously in upper third of shoulder

  3. Live influenza vaccine A/47/S; hybrid of cold‐adapted donor virus A/Leningrad/134/47/57 (H2N2) and A/Sichuan/2/87 (H3N2) ‐ infectious titre 7.3 1 g EID50/0.2cc ‐ re‐immunisation
Outcomes

  1. Cases of acute respiratory illness or influenza in school 1 between 1/1/88 and 1/3/88 (excluding confirmed influenza B diagnosis) i.e. during influenza A(H3N2) outbreak period

  2. Cases of laboratory‐confirmed influenza (H3N2) in school 2 between 16/1/88 and 15/2/88 (excluding confirmed influenza B diagnosis)

  3. Re‐isolation of virus (not for data extraction)

  4. Rise in antibody titre in children inoculated with vaccine strain A/47/S in year 2 (not for data extraction)

  5. Slight increase in temperature (not extractable ‐ no placebo data given)

  6. Subjective events (not extractable ‐ no placebo data given)
Funding Source Government
Notes The authors conclude that bivalent vaccine had better performance (they report protection indices) but the text has so many contradictions, lacks clarity and mentions exclusion of influenza B cases from the analysis that it is impossible to understand what went on. Children from 'internat' roughly translates as state orphanage, could be ethical issues surrounding consent
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 Plausible bias that raises some doubt about the results