Hepatitis B and pertussis antibodies in 4- to 5-year-old children previously vaccinated with different hexavalent vaccines

Figures & data

Table 1. Demographic characteristics of the persistence analysis set.

	3 + 1			2 + 1
Parameter	Group 1 (N = 191)	Group 2 (N = 189)	All (N = 380)	Group 3 (N = 181)	Group 4 (N = 191)	All (N = 372)	All (N = 752)
Gender, n (%)
Female	98 (51.3)	86 (45.5)	184 (48.4)	84 (46.4)	94 (49.2)	178 (47.8)	362 (48.1)
Male	93 (48.7)	103 (54.5)	196 (51.6)	97 (53.6)	97 (50.8)	194 (52.2)	390 (51.9)
Mean age at toddler dose in previous study, months (SD)	12.2 (0.4)	12.2 (0.4)	12.2 (0.4)	11.2 (0.4)	11.2 (0.4)	11.2 (0.4)	11.7 (0.6)
Mean age at the persistence time point, months (SD)	4.8 (0.2)	4.8 (0.2)	4.8 (0.2)	3.9 (0.1)	3.9 (0.1)	3.9 (0.1)	4.4 (0.4)
Mean weight at the persistence time point, kg (SD)	19.2 (2.5)	19.3 (2.6)	19.2 (2.6)	16.9 (2.1)	17.3 (2.4)	17.1 (2.3)	18.2 (2.6)

SD, standard deviation.

Group 1: DTaP5-HB-IPV-Hib (3 + 1): those previously vaccinated with a 3-dose primary series and a toddler dose of DTaP5-HB-IPV-Hib.

Group 2: DTaP3-HB-IPV/Hib (3 + 1): those previously vaccinated with a 3-dose primary series and a toddler dose of DTaP3-HB-IPV/Hib.

Group 3: DTaP5-HB-IPV-Hib (2 + 1): those previously vaccinated with a 2-dose primary series and a toddler dose of DTaP5-HB-IPV-Hib.

Group 4: DTaP3-HB-IPV/Hib (2 + 1): those previously vaccinated with a 2-dose primary series and a toddler dose of DTaP3-HB-IPV/Hib.

Table 2. Summary of anti-HBs responses: persistence analysis set.

		Post-infant		Post-toddler		Persistence
Schedule	Parameter	DTaP5-HB-IPV-Hib	DTaP3-HB-IPV/Hib	DTaP5-HB-IPV-Hib	DTaP3-HB-IPV/Hib	DTaP5-HB-IPV-Hib	DTaP3-HB-IPV/Hib
3 + 1	n	162	165	186	186	Group 1: 191	Group 2: 189
	% ≥10 mIU/mL	98.8	97.0	100.0	100.0	70.2	82.0
	(95% CI)	(95.6, 99.9)	(93.1, 99.0)	(98.0, 100.0)	(98.0, 100.0)	(63.1, 76.5)	(75.8, 87.2)
	% ≥100 mIU/mL	79.6	84.2	96.8	98.4	18.3	39.7
	(95% CI)	(72.6, 85.5)	(77.8, 89.4)	(93.1, 98.8)	(95.4, 99.7)	(13.1, 24.6)	(32.7, 47.0)
	GMC, EU/mL	230	271	3085	4157	24.4	51.3
	(95% CI)	(190, 278)	(225, 326)	(2529, 3762)	(3403, 5077)	(19.5, 30.6)	(40.2, 65.5)
2 + 1	n	104	110	124	131	Group 3: 181	Group 4: 190
	% ≥10 mIU/mL	99.0	98.2	100	100	65.7	83.7
	(95% CI)	(94.8, 100)	(93.6, 99.8)	(97.1, 100)	(97.2, 100)	(58.3, 72.6)	(77.6, 88.6)
	% ≥100 mIU/mL	80.8	86.4	97.6	97.7	17.7	45.3
	(95% CI)	(71.9, 87.8)	(78.5, 92.2)	(93.1, 99.5)	(93.5, 99.5)	(12.4, 24.0)	(38.0, 52.6)
	GMC, EU/mL	255	450	2413	4271	19.4	71.0
	(95% CI)	(199, 327)	(348, 580)	(1946, 2992)	(3334, 5470)	(15.5, 24.4)	(54.9, 91.8)

Anti-HBs, anti-hepatitis B surface antigen; CI, confidence interval; EU, ELISA units; GMC, geometric mean concentration; IU, international units.

Table 3. Summary of pertussis antibodies persistence (responses rate) following a 2 + 1 schedule: persistence analysis set.

		Group 3			Group 4
Antibody	Concentration Endpoint^b	N	n (%)	95% CI^a	N	n (%)	95% CI^a
Anti-PT	≥LLOQ^b	178	104 (58.4)	50.8, 65.8	188	78 (41.5)	34.4, 48.9
	≥2xLLOQ		72 (40.5)	33.2, 48.1		41 (21.8)	16.1, 28.4
	≥4xLLOQ		26 (14.6)	9.8, 20.7		7 (3.7)	1.5, 7.5
Anti-FHA	≥LLOQ	173	140 (80.9)	74.3, 86.5	188	166 (88.3)	82.8, 92.5
	≥2xLLOQ		81 (46.8)	39.2, 54.5		133 (70.7)	63.7, 77.1
	≥4xLLOQ		45 (26.0)	19.7, 33.2		85 (45.2)	38.0, 52.6
Anti-PRN	≥LLOQ	180	119 (66.1)	58.7, 73.0	190	138 (72.6)	65.7, 78.8
	≥2xLLOQ		79 (43.9)	36.5, 51.5		97 (51.1)	43.7, 58.4
	≥4xLLOQ		28 (15.6)	10.6, 21.7		35 (18.4)	13.2, 24.7
Anti-FIM	≥LLOQ	177	167 (94.4)	89.9, 97.3	183	6 (3.3)	1.2, 7.0
	≥2xLLOQ		156 (88.1)	82.4, 92.5		4 (2.2)	0.6, 5.5
	≥4xLLOQ		123 (69.5)	62.1, 76.2		2 (1.1)	0.1, 3.9

^aConfidence intervals were calculated based on the exact binomial method of D. Collett.¹⁵

^bLower limit of quntification (LLOQ) = 4 EU/mL for PT, PRN, and FIM; LLOQ = 3 EU/mL for FHA.

CI, confidence interval; FHA, filamentous hemagglutinin; FIM, fimbriae; PRN, pertactin; PT, pertussis toxin.

Table 4. Summary of pertussis antibodies persistence (GMCs) following a 2 + 1 schedule: persistence analysis set.

	Group 3 (N = 173–180)	Group 4 (N = 183–190)
Anti-PT
GMC, EU/mL (95% CI)	5.3 (4.6, 6.1)	3.6 (3.2, 4.1)
Anti-FHA
GMC, EU/mL (95% CI)	6.6 (5.5, 7.9)	11.1 (9.1, 13.4)
Anti-PRN
GMC, EU/mL (95% CI)	5.9 (5.1, 6.9)	7.2 (6.2, 8.3)
Anti-FIM
GMC, EU/mL (95% CI)	26.0 (21.9, 30.9)	2.1 (2.0, 2.3)

CI, confidence interval; EU, ELISA units; FHA, filamentous hemagglutinin; FIM, fimbriae; GMC, geometric mean concentration; PRN, pertactin; PT, pertussis toxin.

Collett D. Modelling binary data. London, UK: Chapman & Hall/CRC; 2003.

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