Two-year antibody persistence in children vaccinated at 12–15 months with a measles-mumps-rubella virus vaccine without human serum albumin

Figures & data

Figure 1. Disposition of participants in the total vaccinated cohort (persistence phase). ATP, according-to-protocol; MMR: Measles Mumps Rubella vaccine. *For children revaccinated at any point in the study, data were censored from analysis for timepoints after revaccination.

Table 1. Demographic characteristics (ATP cohort for persistence).

Characteristics	Categories	MMR-RIT-1N = 189		MMR-RIT-2 N = 181		MMR-RIT-3 N = 196		M-M-R IIN = 186
Age at dose 1	Mean	12.3		12.3		12.2		12.3
(months)	SD	0.67		0.66		0.55		0.67
		n	%	n	%	n	%	n	%
Gender	Female	98	51.9	87	48.1	100	51.0	79	42.5
	Male	91	48.1	94	51.9	96	49.0	107	57.5
Race	African heritage	14	7.4	15	8.3	16	8.2	18	9.7
	American Indian or Alaskan native	0	0.0	0	0.0	0	0.0	1	0.5
	South East Asian heritage	1	0.5	1	0.6	0	0.0	0	0.0
	Pacific islander	2	1.1	0	0.0	1	0.5	2	1.1
	North African heritage	2	1.1	0	0.0	1	0.5	3	1.6
	European heritage	150	79.4	140	77.3	154	78.6	143	76.9
	Other	20	10.6	25	13.8	24	12.2	19	10.2

MMR-RIT-1: lot 1 of MMR

MMR-RIT-2: lot 2 of MMR

MMR-RIT-3: lot 3 of MMR

M-M-R II: Merck's MMR vaccine

N = total number of children

SD: Standard deviation

n/% = number / percentage of children in a given category

Table 2. Percentage of children with anti-measles, mumps and rubella antibodies in initially seronegative children (ATP cohort for persistence).

Group	Timing	N	n	% (95% CI)	GMC (95% CI)
Anti-measles antibody ≥200 mIU/mL
MMR-RIT-1	D42	182	181	99.5 (97.0−100)	2779.3 (2509.9−3077.7)
	Y1	179	178	99.4 (96.9−100)	3230.2 (2820.4−3699.7)
	Y2	171	171	100 (97.9−100)	3361.1 (2922.3−3865.6)
MMR-RIT-2	D42	172	169	98.3 (95.0−99.6)	3010.1 (2669.0−3394.7)
	Y1	175	172	98.3 (95.1−99.6)	3766.9 (3245.6−4372.0)
	Y2	159	159	100 (97.7−100)	3963.8 (3479.3−4515.7)
MMR-RIT-3	D42	186	184	98.9 (96.2−99.9)	2703.0 (2446.6−2986.3)
	Y1	191	191	100 (98.1−100)	3521.5 (3094.6−4007.3)
	Y2	169	168	99.4 (96.7−100)	3360.3 (2923.3−3862.7)
M-M-R II	D42	178	177	99.4 (96.9−100)	2749.6 (2469.9−3061.0)
	Y1	178	177	99.4 (96.9−100)	3930.4 (3423.3−4512.7)
	Y2	166	166	100 (97.8−100)	4022.1 (3507.7−4611.9)
Anti-mumps (PPD ELISA) ≥10 ELU/mL
MMR-RIT-1	D42	159	152	95.6 (91.1−98.2)	56.8 (48.7−66.3)
	Y1	141	127	90.1 (83.9−94.5)	47.0 (37.9−58.2)
	Y2	136	128	94.1 (88.7−97.4)	47.8 (40.2−56.9)
MMR-RIT-2	D42	153	142	92.8 (87.5−96.4)	43.4 (37.3−50.4)
	Y1	142	129	90.8 (84.9−95.0)	40.1 (33.4−48.0)
	Y2	130	125	96.2 (91.3−98.7)	50.2 (42.1−59.9)
MMR-RIT-3	D42	169	153	90.5 (85.1−94.5)	46.1 (39.5−53.8)
	Y1	154	139	90.3 (84.4−94.4)	43.9 (36.5−52.9)
	Y2	141	136	96.5 (91.9−98.8)	54.0 (46.1−63.3)
M-M-R II	D42	158	148	93.7 (88.7−96.9)	55.3 (47.9−63.8)
	Y1	146	140	95.9 (91.3−98.5)	57.4 (49.1−67.0)
	Y2	140	134	95.7 (90.9−98.4)	59.2 (50.1−70.0)
Anti-mumps (unenhanced PRN assay) ^*≥ 4 ED50
MMR-RIT-1	D42	71	53	74.6 (62.9−84.2)	11.8 (8.4−16.5)
	Y1	161	142	88.2 (82.2−92.7)	33.1 (24.9−44.2)
	Y2	157	144	91.7 (86.3−95.5)	43.4 (33.4−56.3)
MMR-RIT-2	D42	69	55	79.7 (68.3−88.4)	17.3 (11.8−25.4)
	Y1	170	152	89.4 (83.8−93.6)	40.2 (31.0−52.1)
	Y2	144	134	93.1 (87.6−96.6)	48.9 (37.7−63.5)
MMR-RIT-3	D42	73	61	83.6 (73.0−91.2)	16.0 (11.4−22.4)
	Y1	184	161	87.5 (81.8−91.9)	42.7 (32.9−55.4)
	Y2	157	152	96.8 (92.7−99.0)	57.4 (45.7−72.2)
M-M-R II	D42	82	59	72.0 (60.9−81.3)	14.3 (10.3−19.9)
	Y1	167	148	88.6 (82.8−93.0)	46.4 (35.7−60.3)
	Y2	152	144	94.7 (89.9−97.7)	60.7 (47.6−77.5)
Anti-rubella antibody ≥10 IU/mL
MMR-RIT-1	D42	182	180	98.9 (96.1−99.9)	74.3 (66.4−83.1)
	Y1	179	177	98.9 (96.0−99.9)	136.4 (121.4−153.3)
	Y2	171	171	100 (97.9−100)	78.0 (69.7−87.2)
MMR-RIT-2	D42	170	167	98.2 (94.9−99.6)	74.4 (65.8−84.0)
	Y1	174	173	99.4 (96.8−100)	134.8 (121.4−149.8)
	Y2	158	158	100 (97.7−100)	79.5 (71.7−88.2)
MMR-RIT-3	D42	185	182	98.4 (95.3−99.7)	67.8 (61.0−75.5)
	Y1	190	189	99.5 (97.1−100)	135.6 (122.0−150.7)
	Y2	168	168	100 (97.8−100)	81.7 (73.8−90.4)
M-M-R II	D42	178	178	100 (97.9−100)	89.6 (80.3−100.0)
	Y1	178	178	100 (97.9−100)	165.7 (149.4−183.9)
	Y2	166	166	100 (97.8−100)	93.1 (83.6−103.6)

MMR-RIT-1: lot 1 of MMR

MMR-RIT-2: lot 2 of MMR

MMR-RIT-3: lot 3 of MMR

M-M-R II: Merck's MMR vaccine

D42= Post-vaccination blood sample at Day 42

Y1= Antibody persistence blood sample at Year 1

Y2= Antibody persistence blood sample at Year 2

N = number of subjects with available results; n/% = number/percentage of children with concentration above the specified value; 95% CI = 95% confidence interval

GMC= geometric mean antibody concentration calculated on all children

* Enhanced PRN assay was used in the first year and unenhanced PRN assay was used in the second year