Effect of needle size on immunogenicity and reactogenicity of vaccines in infants: randomised controlled trial

Variable

No (%) with reactions by needle size

Differences between needle sizes: relative risk (95% CI)

Wider, longer needle

Narrower, shorter needle

Narrower, longer needle

Wider, longer vnarrower, shorter needle

P value

Narrower, longervwider, longer needle

P value

Combination diphtheria, pertussis, tetanus, and Haemophilus influenzae type b vaccine

First dose:

 Any reaction

162 (69)

174 (78)

139 (62)

0.88 (0.79 to 0.99)

0.03

0.90 (0.79 to 1.03)

0.12

 Any reaction after 24 hours

91 (39)

126 (57)

82 (37)

0.69 (0.56 to 0.84)

0.0001

0.95 (0.75 to 1.20)

0.64

Second dose:

 Any reaction

136 (61)

144 (68)

125 (57)

0.91 (0.79 to 1.04)

0.17

0.92 (0.79 to 1.08)

0.31

 Any reaction after 24 hours

94 (42)

119 (56)

83 (38)

0.76 (0.62 to 0.92)

0.005

0.89 (0.71 to 1.12)

0.30

Third dose:

 Any reaction

137 (64)

136 (67)

106 (50)

0.95 (0.82 to 1.09)

0.44

0.79 (0.67 to 0.94)

0.006

 Any reaction after 24 hours

96 (45)

119 (59)

77 (37)

0.76 (0.63 to 0.92)

0.004

0.82 (0.65 to 1.04)

0.09

Serogroup C meningococcal glycoconjugate vaccine

First dose:

 Any reaction

111 (47)

114 (51)

93 (42)

0.93 (0.77 to 1.12)

0.43

0.88 (0.72 to 1.08)

0.22

 Any reaction after 24 hours

45 (19)

50 (22)

30 (13)

0.87 (0.61 to 1.25)

0.45

0.70 (0.46 to 1.07)

0.10

Second dose:

 Any reaction

84 (38)

79 (37)

92 (42)

1.02 (0.80 to 1.30)

0.90

1.11 (0.88 to 1.39)

0.39

 Any reaction after 24 hours

48 (20)

45 (20)

47 (21)

1.03 (0.71 to 1.48)

0.89

1.03 (0.72 to 1.48)

0.87

Third dose:

 Any reaction

95 (44)

85 (41)

83 (39)

1.04 (0.84 to 1.30)

0.70

0.90 (0.72 to 1.13)

0.38

 Any reaction after 24 hours

59 (25)

57 (25)

42 (19)

0.98 (0.71 to 1.34)

0.90

0.76 (0.54 to 1.09)

0.13