A Cochrane review [Abstract] 1 included 5 studies with a total of 1350 subjects. The evidence from two small trials was insufficient to allow any confident statements to be made.The remaining 3 trials (n=1135) contributed data to comparisons between 25 G 25 mm, 23 G 25 mm, and 25 G 16 mm needles. These trials involved infants predominantly aged two to six months undergoing intramuscular vaccination in the anterolateral thigh. The vaccines administered were combination vaccines containing diphtheria, tetanus, and whole-cell pertussis antigens (DTwP). In some trials, the vaccines also contained Haemophilus influenzae type b (DTwP-Hib) and hepatitis B (DTwP-Hib-HepB) antigen components.There was little or no difference in immune response, defined in terms of the proportion of seroprotected infants, between using 25 G 25 mm, 23 G 25 mm, or 25 G 16 mm needles to administer a series of three doses of a DTwP-Hib vaccine (1 trial, n=309 to 402, moderate quality evidence. 25 mm needles (either 23 G or 25 G) lead to fewer severe local reactions (extensive redness and swelling) and fewer non-severe local reactions (any redness, swelling, tenderness or hardness (composite outcome)) after DTwP-Hib vaccination compared with 25 G 16 mm needles. One fewer infant assessed to experience a severe local reaction after the first vaccine dose for every 25 infants vaccinated with the longer rather than the shorter needle (number needed to treat (NNT) 25 (95% confidence interval (CI) 15 to 100)). One fewer infant was estimated to experience a non-severe local reaction at 24 hours after the first, second, and third vaccine doses for every five to eight infants vaccinated with the longer rather than the shorter needle (NNTs range from 5 (95% CI 4 to 10) to 8 (95% CI 5 to 34)) (moderate quality evidence, one trial for first and second doses, two trials for third dose, numbers of participants in analyses range from 413 to 528).
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