| Methods |
RCT of safety vaccine, double‐blind
0.5 mL of trivalent vaccine administered intranasally
Children observed in own homes for 11 days by nursing staff
Daily sampling ‐ nasopharyngeal swabbing for isolation of influenza virus
Serum for antibody determination obtained on days 0 and 28 to 31. |
| Participants |
Healthy children age 6 months to 13 years |
| Interventions |
Live, trivalent vaccine, recombinant containing A/Kawasaki/9/86 (H1N1) CR125 + A/Korea/1/82 CR59 + B/Texas/1/84 CRB‐87
A/Kawasaki/9/86 and A/Korea/1/82 derived from cold‐adapted A/Ann/Arbor/6/60 parent virus.
B/Texas/1/84 derived from cold‐adapted B/Ann Arbor/1/66 parent virus. |
| Outcomes |
Adverse reactions up to 11 days after vaccination
Fever: rectal temperature > 38.3 °C (infants and young children); oral temperature > 37.8 °C (older children)
Upper respiratory illness: rhinorrhoea on 2 consecutive days; lower respiratory illness; wheeze or pneumonia; OM
Viral shedding (data not extracted)
Serologic response to vaccine (data not extracted) |
| Funding Source |
Government |
| Notes |
Safety data presented separately for seronegative and seropositive responders, but were combined for extraction. Was significantly (P < 0.5) higher upper respiratory illness in seronegative individuals than in seropositive individuals. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
High risk |
Not used |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blinding |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
|
| Summary assessments |
High risk |
Lack of allocation concealment; plausible bias that seriously weakens confidence in the results |
