Safety and immunogenicity of quadrivalent meningococcal polysaccharide vaccine (MPV ACYW135) compared with quadrivalent meningococcal conjugate vaccine (Menactra®) in Malian children

Figures & data

Figure 1. Disposition of study participants.

Table 1. Summary of Demographics at Baseline.

Demographics	All (N = 260)	MPV ACYW135 (N = 130)	Menactra® (N = 130)	P
Sex				.7096^a
Male	125 (48.08%)	64 (49.23%)	61 (46.92%)
Female	135 (51.92%)	66 (50.77%)	69 (53.08%)
Age (years)				.1122^b
Mean (SD)	5.44 (2.37)	5.22 (2.41)	5.67 (2.32)
Median (q1-q3)	6.00 (3.00–7.00)	5.00 (3.00–7.00)	6.00 (4.00–8.00)
Min-Max	2, 10	2, 10	2, 10
Ethnicity				.6214^a
Bambara	112 (43.08%)	56 (43.08%)	56 (43.08%)
Fulani	55 (21.15%)	29 (22.31%)	26 (20.00%)
Sarakole	5 (1.92%)	4 (3.08%)	1 (0.77%)
Senufo	6 (2.31%)	1 (0.77%)	5 (3.85%)
Malinke	54 (20.77%)	27 (20.77%)	27 (20.77%)
Dogon	8 (3.08%)	4 (3.08%)	4 (3.08%)
Songhai	4 (1.54%)	2 (1.54%)	2 (1.54%)
Bobo	1 (0.38%)	1 (0.77%)	0 (0.00%)
Other	15 (5.77%)	6 (4.62%)	9 (6.92%)
Height (cm)				.1563^b
Mean (SD)	111.28 (16.96)	109.75 (16.53)	112.80 (17.30)
Median (q1-q3)	111.50 (98.00–124.50)	110.00 (98.00–123.00)	113.00 (98.00–126.00)
Min-Max	80, 151	80, 145	80, 151
Weight (kg)				.2061^b
Mean (SD)	19.24 (6.38)	18.73 (6.25)	19.74 (6.49)
Median (q1-q3)	18.40 (14.00–22.60)	17.15 (14.10–22.30)	19.20 (13.90–23.10)
Min-Max	8.7, 42.5	8.7, 42.5	9.9, 39.7
Received MenAfriVac® vaccine				-
Yes	260 (100%)	130 (100%)	130 (100%)
No	0 (0.00%)	0 (0.00%)	0 (0.00%)

^aOverall P value (2-sided) based on Chi-square test.

^bOverall P value (2-sided) based on Wilcoxon rank sum test.

N: number of subjects included in each group.

Table 2. Seroconversion rates as defined by proportion of subject with rSBA titers ≥128 at baseline and Day 30 post vaccination in Per-protocol analysis set (PP).

Serogroup	Visit	MPV ACYW135				Menactra®				P
		N	n	%	95% CI	N	n	%	95% CI
A	Baseline	130	129	99.2%	95.8%-100.0%	130	130	100.0%	97.2%-100.0%	1.0000^c
	Day 30	128^d	128	100.0%	97.2%-100.0%	129^e	129	100.0%	97.2%-100.0%	^−a
C	Baseline	130	1	0.8%	0.0%-4.2%	130	5	3.9%	1.3%-8.8%	.2132^c
	Day 30	128^d	113	88.3%	81.4%-93.3%	129^e	117	90.7%	84.3%-95.1%	.5275^b
Y	Baseline	130	69	53.1%	44.1%-61.9%	130	74	56.9%	48.0%-65.6%	.5330^b
	Day 30	128^d	126	98.4%	94.5%-99.8%	128^ef	127	99.2%	95.7%-100.0%	1.0000^c
W	Baseline	130	17	13.1%	7.8%-20.1%	130	23	17.7%	11.6%-25.4%	.3023^b
	Day 30	128^d	114	89.1%	82.3%-93.9%	129^e	119	92.3%	86.2%-96.2%	.3801^b

N = the total number of subjects included in the Per-protocol analysis set in each group.

n = the number of subjects with rSBA titers ≥ 128 in each group.

% = n/N × 100%.

^aNo P value was computed.

^bOverall P value (2-sided) based on Chi-square test.

^cOverall P value (2-sided) based on Fisher’s exact test.

^dTwo subjects in the MPV ACYW135 group did not return at Day 30.

^eOne subject in the Menactra® group did not return at Day 30.

^fOne subject in the Menactra® group had no titer obtained at Day 30.

Table 3. Seroconversion rates as defined by proportion of subject with a rSBA ≥ 4-fold increase at Day 30 post vaccination as compared to baseline in per protocol analysis set (PP).

Serogroup	MPV ACYW135				Menactra®				P
	N	n	%	95% CI	N	n	%	95% CI
A	128^b	67	52.3%	43.3%-61.2%	129^c	59	45.7%	36.9%-54.7%	.2894
C	128^b	118	92.2%	86.1%-96.2%	129^c	121	93.8%	88.2%-97.3%	.6128
Y	128^b	116	90.6%	84.2%-95.1%	128^cd	116	90.6%	84.2%-95.1%	1.0000^a
W	128^b	114	89.1%	82.3%-93.9%	129^c	115	89.2%	82.5%-93.9%	.9825

N = the total number of subjects included in the Per-protocol analysis set in each group.

n = the number of subjects with a rSBA ≥ 4-fold increase in each group.

% = n/N × 100%.

^aOverall P value (2-sided) based on Chi-square test.

^bTwo subjects in the MPV ACYW135 group did not return at Day 30.

^cOne subject in the Menactra® group did not return at Day 30.

^dOne subject in the Menactra® group had no titer obtained at Day 30.

Table 4. Proportion of subjects with rSBA titers ≥8 at baseline and at Day 30 post vaccination in per protocol analysis set (PP).

Serogroup	Visit	MPV ACYW135				Menactra®				P
		N	n	%	95% CI	N	n	%	95% CI
A	Baseline	130	129	99.2%	95.8%-100.0%	130	130	100.0%	97.2%-100.0%	1.0000^c
	Day 30	128^d	128	100.0%	97.2%-100.0%	129^e	129	100.0%	97.2%-100.0%	-^a
C	Baseline	130	6	4.6%	1.7%-9.8%	130	10	7.7%	3.8%-13.7%	.3019^b
	Day 30	128^d	118	92.2%	86.1%-96.2%	129^e	123	95.4%	90.2%-98.3%	.2942^b
Y	Baseline	130	72	55.4%	46.4%-64.1%	130	76	58.5%	49.5%-67.0%	.6163^b
	Day 30	128^d	126	98.4%	94.5%-99.8%	128^ef	127	99.2%	95.7%-100.0%	1.0000^c
W	Baseline	130	21	16.2%	10.3%-23.6%	130	25	19.2%	12.9%-27.1%	.5156^b
	Day 30	128^d	115	89.8%	83.3%-94.5%	129^e	119	92.3%	86.2%-96.2%	.4995^b

N = the total number of subjects included in the Per Protocol analysis set in each group.

n = the number of subjects with rSBA tiers ≥ 8 in each group.

% = n/N × 100%.

^aNo P value was computed.

^bOverall P value (2-sided) based on Chi-square test.

^cOverall P value (2-sided) based on Fisher’s exact test.

^dTwo subjects in the MPV ACYW135 group did not return at Day 30.

^eOne subject in the Menactra® group did not return at Day 30.

^fTiter was not measured for 1 subject in the Menactra® group due to insufficient serum aliquot.

Figure 2. Reverse Cumulative Distribution Curves of baseline rSBA titers - per-protocol analysis set (PP): blue curves stand for MPV ACYW135, and red curves stand forMenactra®.

Figure 3. Reverse Cumulative Distribution Curves of rSBA titers 30 Days after Immunization - per-protocol analysis set (PP): blue curves stand for MPV ACYW135, and red curves stand for Menactra®.

Table 5. Comparison of rSBA geometric mean titers between baseline and Day 30 post vaccination in per protocol analysis set (PP).

Serogroup	Study Group	Baseline GMT (95% CI)	Day 30 post Vaccination GMT (95% CI)	Geometric Mean Fold Increase from Baseline (95% CI)	P^a
A	MPV ACYW135	1,611.1 (1,315.1–1,973.7)	5,577.2 (4,852.0–6,410.6)	3.5 (2.9–4.2)	<.0001*
	Menactra®	2,081.0 (1,809.0–2,393.9)	6,295.7 (5,622.2–7,050.0)	3.0 (2.6–3.5)
	P^b	0.0410	0.1822	0.2662
C	MPV ACYW135	2.4 (2.1–2.7)	348.6 (247.7–490.5)	148.2 (105.4–208.2)	<.0001*
	Menactra®	2.7 (2.2–3.3)	490.5 (363.1–662.5)	180.5 (128.3–254.0)
	P^b	0.2144	0.1385	0.4176
Y	MPV ACYW135	38.4 (23.7–62.1)	2,627.3 (2,033.4–3,394.8)	68.7 (43.4–108.7)	<.0001*
	Menactra®	49.0 (30.2–79.7)	3,008.2 (2,410.7–3,753.8)	58.4 (36.6–93.2)
	P^b	0.4784	0.4296	0.6241
W	MPV ACYW135	4.8 (3.3–6.8)	985.9 (630.9–1,540.8)	203.9 (132.6–313.6)	<.0001*
	Menactra®	6.0 (4.0–9.0)	1,459.9 (966.9–2,204.2)	240.0 (150.2–383. 5)
	P^b	0.3899	0.2021	0.6128

^aPaired t test was used to calculate P values. GMT titer between baseline and Day 30 were compared.

^bIndependent t test was used to calculate P values. GMT titer between vaccine groups were compared.

*P value ≤ .05 is considered statistically significant.

Table 6. Number (%) of subjects with solicited local and systemic reactions within 30 minutes to Day 7 post vaccination by severity.

	MPV ACYW135		Menactra®		P
	(N = 130)		(N = 130)
	n	%	n	%
Any Solicited Local Reactions					1.0000^b
Mild	2	1.5%	3	2.3%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%
Pain					1.0000^b
Mild	2	1.5%	3	2.3%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%
Swelling/Induration					-^a
Mild	0	0.0%	0	0.0%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%
Any Solicited Systemic Reactions					.6221^b
Mild	1	0.8%	4	3.1%
Moderate	1	0.8%	0	0.0%
Severe	0	0.0%	0	0.0%
Fever					.4980^b
Mild	0	0.0%	2	1.5%
Moderate	1	0.8%	0	0.0%
Severe	0	0.0%	0	0.0%
Irritability					^−a
Mild	0	0.0%	0	0.0%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%
Loss of appetite					1.0000^b
Mild	1	0.8%	1	0.8%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%
Drowsiness					-^a
Mild	0	0.0%	0	0.0%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%
Vomiting					1.0000^b
Mild	0	0.0%	1	0.8%
Moderate	0	0.0%	0	0.0%
Severe	0	0.0%	0	0.0%

N: number of subjects included in each group.

n: number of subjects who reported corresponding adverse events.

% = n/N × 100%.

^aNo P value was computed.

^bOverall P value (2-sided) based on Fisher’s exact test.

Table 7. Number (%) of subjects with at least one unsolicited adverse events between Day 0 to Day 30 by severity.

Severity of Adverse Events	MPV ACYW135		Menactra®
	(N = 130)		(N = 130)
	n	%	n	%
Any	12	9.23%	14	10.77%
Mild	2	1.54%	1	0.77%
Moderate	10	7.69%	13	10.00%
Severe	0	0.00%	0	0.00%

Subject ID 1106 in Menactra® group reported 2 AEs, of which one was “RHINITIS” and the other was “ECZEMA” as counted in this table.

N: number of subjects included in each group.

n: number of subjects who reported corresponding adverse events.

% = n/N × 100%.