| Methods |
Randomisation: no details
Blinding: unclear
Number excluded: none?
Withdrawals: 6/20 vaccine group, 8/25 placebo group discharged from hospital
Baseline characteristics: serology only
Jadad score: 2 |
| Participants |
Location: Minami‐Fukuoka Chest Hospital, Japan. In‐patients on asthma ward.
Number and age of participants: 45 children, mean age 10.5 years (standard deviation 2.5)
Asthma definition and severity: institutionalised patients with bronchial asthma (no details)
Inclusion criteria: inpatients in asthma ward
Exclusion criteria: not stated |
| Interventions |
Vaccination type: intranasal cold‐adapted recombinant trivalent influenza vaccine (H1N1, H3N2, B). Dose 0.3 mL both nostrils by nasal spray
Placebo: saline inoculation |
| Outcomes |
Early: "asthma attacks", school absence
Late: confirmed influenza (virus isolation or confirmed 4‐fold antibody rises with fever) |
| Notes |
Baseline serology was similar in vaccinated and placebo groups |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
No details |
| Allocation concealment (selection bias) |
Unclear risk |
No details |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No details |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No details |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
High proportion of withdrawals (14/45) |
