| Study characteristics |
| Methods |
A randomised double‐blind placebo controlled study over 1 year. |
| Participants |
People with CF (n = 55) attending the CF Clinic of the St Vincent's Hospital in New York, USA. |
| Interventions |
An intranasal bivalent cold adapted influenza A vaccine (A/Dunedin/83 CR‐64 (H1N1), A/Korea/1/82 CR‐59 (H3N2)) plus monovalent inactivated influenza B 1 week later versus intranasal placebo plus parenteral trivalent inactivated influenza vaccine (A/Chile/83 (H1N1), A/Philippines/82 (H3N2) & B/USSR/100/83). |
| Outcomes |
1. Adverse effects
2. Antibody level |
| Notes |
Antibody levels taken before, 3 weeks and 7 months after vaccination. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Described as 'randomly assigned' but no details given as to the method. |
| Allocation concealment (selection bias) |
Unclear risk |
Not discussed. |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Described as double‐blind, similar treatments i.e. intranasal followed by parenteral dose of active vaccine or placebo. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Does not report drop outs, but clear from paper that at least 2 data sets are missing from each group. |
