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Table 3 Immune responses to pneumococcal polysaccharides at one month post-primary vaccination (primary ATP immunogenicity cohort): OPA

From: A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzaeprotein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia

 

Clin group

Com group

 

N

% ≥8

GMT

N

% ≥8

GMT

(95% CI)

(95% CI)

(95% CI)

(95% CI)

Vaccine serotypes

      

Serotype 1

209

88.5

128.9

210

90.0

122.1

(83.4 – 92.5)

(102.7 – 161.7)

(85.1 – 93.7)

(98.3 – 151.7)

Serotype 4

207

100

698.3

207

98.1

609.3

(98.2 – 100)

(619.6 – 786.9)

(95.1 – 99.5)

(519.6 – 714.3)

Serotype 5

207

98.6

127.9

210

96.7

98.6

(95.8 – 99.7)

(109.0 – 149.9)

(93.3 – 98.6)

(83.0 – 117.1)

Serotype 6B

205

95.6

870.7

206

92.7

619.2

(91.8 – 98.0)

(710.2 – 1067.6)

(88.3 – 95.9)

(483.4 – 793.2)

Serotype 7F

206

100

3905.8

208

100

3585.7

(98.2 – 100)

(3420.2 – 4460.4)

(98.2 – 100)

(3119.8 – 4121.2)

Serotype 9V

207

100

1800.0

208

100

1851.3

(98.2 – 100)

(1596.6 – 2029.3)

(98.2 – 100)

(1612.3 – 2125.8)

Serotype 14

209

99.5

1521.0

208

99.5

1485.8

(97.4 – 100)

(1313.3 – 1761.6)

(97.4 – 100)

(1280.5 – 1724.0)

Serotype 18C

204

99.0

533.5

206

96.6

383.9

(96.5 – 99.9)

(461.8 – 616.4)

(93.1 – 98.6)

(319.3 – 461.5)

Serotype 19F

206

98.1

689.6

206

97.1

573.5

(95.1 – 99.5)

(581.1 – 818.2)

(93.8 – 98.9)

(477.2 – 689.3)

Serotype 23F

209

99.0

2716.7

207

99.5

2379.5

(96.6 – 99.9)

(2316.3 – 3186.3)

(97.3 – 100)

(2043.4 – 2770.7)

Cross-reacting serotypes

      

Serotype 6A

197

87.8

230.8

200

85.5

173.7

(82.4 – 92.0)

(180.3 – 295.4)

(79.8 – 90.1)

(133.9 – 225.3)

Serotype 19A

197

42.1

18.1

199

37.7

15.1

(35.1 – 49.4)

(13.7 – 23.8)

(30.9 – 44.8)

(11.5 – 19.8)

  1. ATP = according to protocol.
  2. OPA = opsonophagocytic activity.
  3. Clin = group of infants from Malaysia and Singapore who received the Phase III Clinical lot of PHiD-CV in the primary vaccination phase.
  4. Com = group of infants from Malaysia and Singapore who received the Commercial lot of PHiD-CV in the primary vaccination phase.
  5. N = number of infants with available results.
  6. 95% CI = 95% confidence interval.
  7. GMT = geometric mean titre.
  8. % = percentage of infants with antibody concentrations or OPA titres above the specified cut-off.