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Q Is vaccination of infants with a wide long needle equivalent or superior to a narrow short needle for immune response and local reactions?
METHODS
Design:
randomised controlled non-inferiority trial.
Allocation:
concealed.
Blinding:
blinded (data entry clerks and laboratory staff).
Follow up period:
3 to 4.5 months.
Setting:
18 general practices in 2 primary care trusts in the UK.
Participants:
696 healthy infants due to receive their first immunisation (mean age 62 d, mean weight 5300 g, 52% boys). Exclusion criteria were <37 weeks gestation, birth weight <2500 g, or treatments or conditions that could bias evaluation of immune response.
Intervention:
vaccination with a 23 gauge, 25 mm needle (wide long needle, n = 240), a 25 gauge, 16 mm needle (narrow short needle, n = 230), or a 25 gauge, 25 mm needle (narrow long needle, …
Footnotes
For correspondence: MsL Diggle, Department of Paediatrics, University of Oxford, Oxford, UK. linda.diggle{at}paediatrics.ox.ac.uk
Sources of funding: National Health Service Executive South East and Becton Dickinson.