Meningococcal quadrivalent tetanus toxoid conjugate vaccine (MenACWY-TT, Nimenrix™): A review of its immunogenicity, safety, co-administration, and antibody persistence

Figures & data

Table 1. Neisseria meningitidis serogroup distribution in different regions and the estimated vaccine preventable meningococcal disease.

		Serogroup Distribution (% of total)^§
Region	Representative Countries	A	C	W	Y	B	X^**	ACWY Vaccine-Preventable	B-Vaccine Preventable
North America	USA^73		36		9	26		≥ 45%	26%
	Canada^74		20		13	54		≥ 33%	54%
South America	Brazil^75		55	5	2	38		≥ 62%	38%
	Argentina^75		11	13	7	69		≥ 31%	69%
Europe			13		4	71		≥ 17%	71%
Middle East	Saudi Arabia^76			36				≥ 36%
Africa	African Meningitis Belt^*^74	91		8				≥ 99%
	South Africa^77		10	43	4	18		≥ 57%	18%
South East Asia	China^78	16.4	61.2			4.5		≥ 77%	4.5%
	Japan^79			1	39	57		≥ 40%	57%
Australia			6			85		≥ 6%	85%

Notes. ^§Data are from most recently available references for the different regions.

* Countries include: Gambia, Senegal, Guinea-Bissau, Guinea, Mali Burkina Faso, Ghana, Niger, Nigeria, Cameroon, Chad, Central African Republic, Sudan, South Sudan, Uganda, Kenya, Ethiopia, Eritrea, Togo, Benin, Cote D'Ivoire, Mauritania, Tanzania, Burundi, Rwanda, Democratic Republic of Congo.

** Serogroup X has only recently emerged as an important cause of outbreaks in the African meningitis belt mostly following the introduction of MenA conjugate vaccine. In Burkina Faso during 2011, 59% of confirmed meningococcal cases were due to MenX.²⁹ In southwestern Niger, incidence reached 90% for MenX during the 2006 outbreak.¹²

Table 2. Summary of the main results of phase III clinical trials on co-administration of MenACWY-TT with other vaccines.

Author	Country	Age	Co-administration group	Immunogenicity	Safety	Notes
Knuf et al.^68 2011	Austria, Germany, Greece	12 to 23 months	MenACWY-TT +Infanrix™ Hexa, GSK	97.3% had rSBA titres ≥1:8 and at least 88.2% had titres ≥1:128 for all four serogroups. 99.4% had anti-D and anti-T concentrations ≥0.1 IU/ml. All subjects were seropositive for antibodies against pertussis; all subjects had seroprotective antibodies against Hib. At least 98.2% had seroprotective antibodies against hepatitis B and each of the three poliovirus types.	AEs were within the same range for all groups. Pain, redness and swelling at site of injection were more frequent in the Coad groups.	Higher percentages with rSBA ≥1:8 for serogroups C & Y in the Coad group. Lower anti-tetanus and anti-Hepatitis B antibodies in the Hexa/ACWY than in the ACWY/Hexa group.
Vesikari et al.^45 2011	Finland	12 to 23 months	MenACWY-TT +Priorix™ Tetra, GSK	Co-administration was non-inferior to administering vaccines at separate visits. 99.7% of subjects had rSBA titers ≥1:8 against each vaccine serogroup. All seroconverted against measles and rubella, 83.3%–87% 97.9% (Coad) against varicella	Comparable safety profile for all groups. Fever and rash due to the measles component was similar in all groups.	Lower anti-rubella GMCs in the Coad group. Higher rSBA titers against serogroup C in the ACWY-TT groups than in the MenC group
Ostergaard et al. ^66 2012	Sweden, Denmark	11 to 17 years	MenACWY-TT +Twinrix™, GSK	All subjects achieved rSBA titers ≥ 1:128 after 1^st dose of ACWY-TT for each serogroup in both groups. All subjects were seropositive for hepatitis A and achieved seroprotection against hepatitis B after 3^rd dose of HepA/B in both groups.	Safety profile was similar for both groups.	Significantly lower rSBA GMTs to serogroup C noted in the Coad group
Aplasca-De Los Reyes et al.^63 2012	Lebanon, Philippines	18 to 55 years	MenACWY-TT + Fluarix™,GSK	99.0% and 97.1% of subjects in all vaccine groups achieved rSBA titers ≥ 1:8 and ≥1:128 respectively, for each of the four serogroups. The Coad group met all pre-defined statistical criteria for antibody responses against influenza antigens A/H1N1, A/H3N2 and B.	Safety profile was similar for all groups. Pain at injection site and headache were the two most frequently reported symptoms.
Ruiz-Palacios et al.^67 2013	Mexico, Taiwan	12 to 23 months	MenACWY-TT + Synflorix™, GSK	96% of the toddlers reached antibody concentrations ≥ 0.2 µg/ml for each pneumococcal serogroup in all studied groups. At least 97.5% achieved r SBA titers ≥1:128 to each meningococcal serogroup in all studied groups.	Safety profile was similar for both groups.	Non-inferiority criteria of co-administration over PHiD-CV alone was not met for serotype 18C
Leonardi et al.^69 2015	USA	2 months	MenACWY-TT +Infanrix™, GSK	99% had anti-tetanus and anti-diphtheria protective titers. All but one were seropositive for antibodies against pertussis antigens.		Lower post vaccination antibody GMCs for pertussis antigens in the 3 groups compared to the control group. Immunogenicity and vaccine response to MenACWY-TT when co-administered with DTaP were not evaluated

Note. Infanrix Hexa, DTaP-HepB-Hib/IPV; Priorix Tetra, MMRV; Twinrix, HepA/B; Fluarix, influenza vaccine; Synflorix, ten-valent pneumococcal vaccine; Infanrix, DTaP.

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