| 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 day 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 is made of the missing children. We believe the data are 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 is made of the missing children. |
| Summary assessments |
High risk |
Data are uninterpretable. |
