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Q Is vaccination of infants with a wide long needle non-inferior to a narrow short needle for immune response and local reactions?
Clinical impact ratings Paediatrics ★★★★★★★ Infectious disease ★★★★★★☆ Public health ★★★★★★☆
METHODS
Design:
randomised controlled non-inferiority trial.
Allocation:
concealed.*
Blinding:
blinded (data entry clerks and laboratory staff).*
Follow up period:
3–4.5 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:
infants were allocated to 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, n = 226). At 2, 3, and 4 months of age, infants received a …
Footnotes
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↵* See glossary.
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For correspondence:
Dr L Diggle
University of Oxford, Oxford, UK. linda.diggle{at}paediatrics.ox.ac.uk -
Sources of funding: NHS Executive South East Research and Development Project.