Conjugate Meningococcal Vaccines Development: GSK Biologicals Experience

Table 4

hSBA-MenC, hSBA-MenY antibody responses after Hib-MenCY-TT vaccination.

Reference	Vaccine dose 1–3	Vaccine dose 4	Timepoint	𝑁	hSBA ≥ 1 : 4		hSBA ≥1 : 8		GMT
					%	[95% CI]	%	[95% CI]	Value	[95% CI]
hSBA-MenC
Marchant et al., 2010 [82] & Marshall et al., 2010 [83] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + 7vCRM	PD3	121	97.5	[92.9–99.5]	95.9	[90.6–98.6]	523.0	[398.8–686.0]
			Pre-D4	63	90.5	[80.4–96.4]	90.5	[80.4–96.4]	71.8	[48.0–107.5]
			PD4	65	96.9	[89.3–99.6]	96.9	[89.3–99.6]	657.1	[438.4–984.8]
			PD4 (Y1)	116	96.6	[91.4–99.1]	96.6	[91.4–99.1]	150.1	[116.5–193.4]
	Hib-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + 7vCRM	PD4	35	94.3	[80.8–99.3]	94.3	[80.8–99.3]	72.5	[46.4–113.3]
			PD4 (Y1)	48	70.8	[55.9–83.0]	70.8	[55.9–83.0]	26.3	[14.8–46.5]
Nolan et al., 2011 [84] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + MMR + VAR	PD3	83	100	[95.7–100]	100	[95.7–100]	379	[295–489]
			Pre-D4	134	93.3	[87.6–96.9]	93.3	[87.6–96.9]	97.7	[74.0–129]
			PD4	132	99.2	[95.9–100]	99.2	[95.9–100]	1808	[1398–2337]
	MenC-CRM197 + Hib-TT + 7vCRM; DTPa-HBV-IPV	Hib-MenCY-TT + MMR + VAR	PD3	28	100	[87.7–100]	100	[87.7–100]	254	[193–335]
			Pre-D4	54	85.2	[72.9–93.4]	85.2	[72.9–93.4]	34.6	[22.8–52.6]
			PD4	43	95.3	[84.2–99.4]	95.3	[84.2–99.4]	172	[94.7–311]
Bryant et al., 2011 [85] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + DTPa-HBV-IPV + 7vCRM (Mexico)	Hib-MenCY-TT + MMR + VAR	PD3	134	99.3	[95.9–100]	99.3	[95.9–100]	3172.6	[2657.9–3786.8]
			PD4	39	100	[91.0–100]	100	[91.0–100]	10132.9	[8008.0–12821.7]
	Hib-MenCY-TT + DTPa-HBV-IPV + 7vCRM (US)	Hib-MenCY-TT + MMR + VAR	PD3	491	98.8	[97.4–99.6]	98.8	[97.4–99.6]	967.6	[864.0–1083.5]
			Pre-D4	420	96.0	[93.6–97.6]	96.0	[93.6–97.6]	176.5	[153.9–202.4]
			PD4	331	98.5	[96.5– 99.5]	98.5	[96.5– 99.5]	2039.8	[1746.3–2382.6]
hSBA-MenY
Marchant et al., 2010 [82] & Marshall et al., 2010 [83] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + 7vCRM	PD3	141	91.5	[85.6–95.5]	89.4	[83.1–93.9]	139.8	[102.6–190.5]
			Pre-D4	66	54.5	[41.8–66.9]	50.0	[37.4–62.6]	12.2	[7.7–19.1]
			PD4	65	95.4	[87.1–99.0]	95.4	[87.1–99.0]	246.6	[168.0–362.1]
			PD4 (Y1)	105	84.8	[76.4–91.0]	83.8	[75.3–90.3]	128.8	[86.2–192.5]
	Hib-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + 7vCRM	PD4	35	60.0	[42.1–76.1]	57.1	[39.4–73.7]	11.1	[6.5–19.0]
			PD4 (Y1)	47	66.0	[50.7–79.1]	66.0	[50.7–79.1]	41.1	[20.4–82.9]
Nolan et al., 2011 [84] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + 7vCRM + DTPa-HBV-IPV	Hib-MenCY-TT + MMR + VAR	PD3	85	100	[95.8–100]	100	[95.8–100]	86.4	[68.9–108.3]
			Pre-D4	114	91.2	[84.5–95.7]	90.4	[83.4–95.1]	81.2	[58.6–112.6]
			PD4	122	97.5	[93.0–99.5]	97.5	[93.0–99.5]	1002	[741–1356]
Bryant et al., 2011 [85] 2, 4, 6 + 12–15 months of age	Hib-MenCY-TT + DTPa-HBV-IPV + 7vCRM (Mexico)	Hib-MenCY-TT + MMR + VAR	PD3	135	99.3	[95.9–100]	99.3	[95.9–100]	837.2	[696.4–1006.3]
			PD4	40	100	[91.2–100]	100	[91.2–100]	5775.8	[4488.9–7431.7]
		Hib-MenCY-TT + DTPa-HBV-IPV + 7vCRM (US)	Hib-MenCY-TT + MMR + VAR	PD3	481	96.3	[94.2–97.8]	95.8	[93.7–97.4]	236.6	[205.7–272.1]
	Pre-D4			419	93.6	[90.8–95.7]	92.8	[89.9–95.1]	117.5	[101.3–136.2]
	PD4			342	98.8	[97.0–99.7]	98.8	[97.0–99.7]	1389.5	[1205.0–1602.2]

𝑁: numbers of subjects with available data, 95% CI: 95% confidence interval, GMT: Geometric Mean Titre, %: percentage of subjects with titre within the specified range, PD3: one month after dose 3 (ATP Cohort for Immunogenicity), Pre-D4: just prior dose 4 (ATP Cohort for Persistence), PD4: one month after dose 4 (ATP Cohort for Immunogenicity), PD4 (Y1): one year after dose 4 (ATP cohort for Persistence Year 1), Results of this table were previously published [82–85].