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. 2014 Mar 6;2014(3):CD001753. doi: 10.1002/14651858.CD001753.pub3

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