ab Obrosova‐Serova 1990.
Methods | Randomised, single‐blind, placebo‐controlled trial to assess reactogenicity in children of live attenuated cold‐adapted influenza B vaccine | |
Participants | "The study was conducted in a children's nursery and in a children's boarding school. 109 children and 87 children 3 to 15 years old received respectively vaccine or placebo" | |
Interventions | Enrolled participants were randomised to receive at least 1 dose or 2 doses of live attenuated cold‐adapted influenza B vaccine derived by reassortment between wild‐type B/Ann Arbor/1/86 and cold‐adapted B/Leningrad/14/55 viruses. First dose of vaccine or placebo was administered at day 0 and second dose after 3 weeks. 0.5 mL vaccine or placebo was administered intranasally by aerosol spray. Placebo consisted of distilled water. At the time of the study no evidence of circulation of influenza B viruses in Moscow was reported to the laboratory responsible for surveillance in the region. | |
Outcomes |
Serological
HI titre against LEN‐B/14/5/1 reassortant virus. Sera were collected by finger stick before the first and second inoculations and 3 weeks later. Effectiveness N/A Safety Adverse reactions were defined as fever (axillary temperature > 37.5 °C) and upper respiratory symptoms (coryza or pharyngitis, or both) observed for 4 days after each inoculation. |
|
Funding Source | Government | |
Notes | The authors conclude that the vaccine was immunogenic in younger children but less so in older children. There was lot of unexplained attrition between the first and second inoculations. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description |
Allocation concealment (selection bias) | Unclear risk | Not used |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Single‐blinding |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was lot of unexplained attrition between the first and second inoculations. |
Summary assessments | High risk | There was lot of unexplained attrition between the first and second inoculations. |