Schaad 2000.
Study characteristics | ||
Methods | An open randomised multicentre study over 4 weeks. | |
Participants | Children with CF (n = 64) in 5 paediatric centres in Switzerland. | |
Interventions | A trivalent virosomal influenza vaccine (ASingapore/6/86 (H1N1); A/Shandong/9/93 (H3N2) B/Panama/45/90) (given as either single or 2 doses 4 weeks apart) versus a trivalent subunit influenza vaccine (A/Singapore/6/86 (H1N1); A/Shandomg/9/93 (H3N2); B/Panama/45/90) (given as 1 or 2 doses 4 weeks apart). | |
Outcomes | 1. Adverse effects 2. Antibody level rise | |
Notes | Antibody levels taken before and 4 weeks after the single or the second immunisation. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no details of method given. |
Allocation concealment (selection bias) | Unclear risk | Not discussed. |
Blinding (performance bias and detection bias) All outcomes | High risk | Not possible as dose regimens in the treatment groups differ ‐ some participants received a single injection and others received two injections. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | States number of withdrawals, but does not give details of which treatment group they were from or the reason for withdrawal. |
CF: cystic fibrosis IM: intramuscular