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Vaccinating infants with a wide long needle was non-inferior to a narrow short needle for immune response

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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

Embedded ImageDesign:

randomised controlled non-inferiority trial.

Embedded ImageAllocation:

concealed.*

Embedded ImageBlinding:

blinded (data entry clerks and laboratory staff).*

Embedded ImageFollow up period:

3–4.5 months.

Embedded ImageSetting:

18 general practices in 2 primary care trusts in the UK.

Embedded ImageParticipants:

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.

Embedded ImageIntervention:

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 …

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