Hypodermic needles of different sizes (gauges and lengths) can be used for vaccination procedures. The gauge (G) refers to the outside diameter of the needle tubing. The higher the gauge number, the smaller diameter of the needle (eg a 25 G needle is 0.5 mm in diameter and is narrower than a 23 G needle (0.6 mm)). Many
vaccines are recommended for injection into muscle (intramuscularly), although some are delivered subcutaneously (under the skin) and intradermally (into skin). Choosing an appropriate length and gauge of a needle may be important to ensure that a
vaccine is delivered to the appropriate site and produces the maximum immune response while causing the least possible harm. There are some conflicting guidelines regarding the lengths and gauges of needles that should be used for vaccination procedures in children and adolescents.
OBJECTIVES: We searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 10), MEDLINE and MEDLINE in Progress via Ovid (1947 to November 2014), EMBASE via Ovid (1974 to November 2014), and CINAHL via EBSCOhost (1982 to November 2014). We also searched reference lists of articles and textbooks, the proceedings of
vaccine conferences, and three clinical trial registers.
SELECTION CRITERIA: Three review authors independently extracted trial data and assessed the risk of bias. We contacted trial authors for additional information. We rated the quality of evidence using the GRADE system.
MAIN RESULTS: We included five trials involving 1350 participants. Data for the primary review outcomes were either absent (for the incidence of
vaccine-preventable diseases) or limited (for
procedural pain and crying). The available evidence was compromised by the use of surrogate immunogenicity outcomes, incomplete blinding of outcome assessors, and imprecision for some outcomes. The evidence from two small trials was insufficient to allow any confident statements to be made about the effects of the needles evaluated in the trials on vaccine immunogenicity and reactogenicity.The remaining three trials (1135 participants) 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 using the World Health Organization (WHO) injection technique (skin stretched flat, needle inserted at a 90° angle and up to the needle hub in healthy infants). 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.We found moderate quality evidence from one trial that there is probably 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 at ages two, three, and four months (numbers of participants in analyses range from 309 to 402. Immune response to
pertussis antigen not measured).25 mm needles (either 23 G or 25 G) probably 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. We estimate that one fewer infant will 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)). We estimate that one fewer infant will 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).Using a wider gauge needle (23 G 25 mm) may slightly reduce
procedural pain (low quality evidence) and probably leads to a slight reduction in the duration of crying time immediately after vaccination (moderate quality evidence) compared with a narrower gauge (25 G 25 mm) needle (one trial, 320 participants). The effects are probably not large enough to be of any clinical relevance. The 25 G 25 mm needle may produce a small reduction in the incidence of local reactions after each dose of a
DTwP vaccine compared with the 23 G 25 mm needle, but the effect estimates are imprecise (low quality evidence, two trials, numbers of participants in analyses range from 100 to 459).The comparative effects of 23 G 25 mm, 25 G 25 mm, and 25 G 16 mm needles on the incidence of post-vaccination
fever, persistent inconsolable crying, and other systemic events such as drowsiness, loss of appetite, and
vomiting are uncertain due to the very low quality of the evidence.
AUTHORS' CONCLUSIONS: Using 25 mm needles (either 23 G or 25 G) for intramuscular vaccination procedures in the anterolateral thigh of infants using the WHO injection technique probably reduces the occurrence of local reactions while achieving a comparable immune response to 25 G 16 mm needles. These findings are applicable to healthy infants aged two to six months receiving combination DTwP
vaccines with a reactogenic whole-cell
pertussis antigen component. These
vaccines are predominantly used in developing countries. The applicability of the findings to
vaccines with acellular
pertussis components and other
vaccines with different reactogenicity profiles is uncertain.