ab Rudenko 1991

Methods	RCT of live vaccines Influenza virus B ‐ B/14/5/1 produced by recombination of 2 surface antigens (HA and NA) from epidemic strain B/Ann Arbor/2/86 and 6 "core" antigens from attenuated donor strain B/Leningrad/14/17. Activity of B/14/5/1 7.0 IU of EIE50 in 0.2 ml. (EIE = Experimental Immunogenic Effect in 50% experimental participants) Commercially available influenza vaccine A (H1N1) A/Taiwan/1/87 also used, with biological activity of 7.0 IU of EIE50/0.2 ml Children randomised into 4 groups with 1 child serving as a sample unit All treatments were administered in 2 x 0.5 ml doses by intranasal spray using Smirnov apparatus. 21 interval between first and second doses Children followed up for 5 days after each dose Immunogenicity of vaccine determined using reaction of haemagglutinin deceleration and ELISA developed for influenza B virus
Participants	1009 children age 3 to 14 years
Interventions	Influenza virus B ‐ B/14/5/1 (recombinant) Commercial influenza A vaccine ‐ A/Taiwan/1/87 (H1N1)
Outcomes	Mild fever (31.7 to 37.5°C), moderate fever, malaise, headache, rhinorrhoea, nasal stuffiness, cough, hoarse voice, sore throat, nasal bleeding, conjunctivitis Seroconversion (data not extracted) Mean antibody titres (data not extracted) Increase in ELISA titre (data not extracted)
Funding Source	Unclear
Notes	The text refers to 4 randomised arms with a total denominator of 1009 (this is not a mistranslation as we have checked the original in Arab numerals). Table 2 reports data on 321 children. No mention of the missing children is made. We believe the data is uninterpretable
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No description
Allocation concealment (selection bias)	High risk	Not used
Blinding (performance bias and detection bias) All outcomes	Unclear risk	No description
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No mention of the missing children is made
Summary assessments	High risk	Data are uninterpretable