Meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine: a new conjugate vaccine against invasive meningococcal disease

Figures & data

Figure 1 Global serogroup distribution of invasive meningococcal disease.

Notes: A, serogroup A meningococcus; B, serogroup B meningococcus; C, serogroup C meningococcus; W-135, serogroup W-135 meningococcus; Y, serogroup Y meningococcus; X, serogroup X meningococcus.

Table 1 Polysaccharide vaccines

	Serogroups	Manufacturer
Bivalent vaccines
AC vax	A and C	GlaxoSmithKline, plca
Mengivac	A and C	Sanofi-Pasteura
Trivalent vaccines
Trivalent vaccine (group A, C, and W-135)	A, C, and W-135	GlaxoSmithKline, plca
Quadrivalent vaccines
ACWY vax (Mencevax)	A, C, W-135, and Y	GlaxoSmithKline, plc
Menomune	A, C, W-135, and Y	Sanofi-Pasteurb

Notes:

a Although these vaccines are still licensed in Europe, they are no longer available

b available in the USA and Canada. Manufacturer details: GlaxoSmithKline plc, Brentford, UK; Sanofi-Pasteur, Lyon, France.

Table 2 Meningococcal conjugate vaccines

Vaccine	Composition	Manufacturer	Age group
Monovalent vaccines
Meningitec	MenC-CRM	Pfizer, Inc.	≥2 months
Menjugate	MenC-CRM	Novartis Vaccines	≥2 months
NeisVac-C	MenC-TT	Baxter International Inc.	≥2 months
MenAfrivac	MenA-TT	Serum Institute of India	1–29 years
Quadrivalent vaccines
Menveo	MenACWY-CRM	Novartis Vaccines	11–55 years 2–10 years 2–23 months
Menactra	MenACWY-DT	Sanofi-Pasteur	11–55 years 2–10 years 9–23 months
Nimenrix	MenACWY-TT	GlaxoSmithKline, plc	≥12 months
Combination vaccines
MenHibrix	Hib-MenCY-TT	GlaxoSmithKline, plc	6 weeks to 18 months
Menitorix	Hib-MenC-TT	GlaxoSmithKline, plc	Primary series: 6 weeks to 12 months Booster:12 months to 2 years

Notes: Manufacturer details: Baxter International Inc., Deerfield, IL, USA; GlaxoSmithKline plc, Brentford, UK; Novartis Vaccines, Siena, Italy; Pfizer, Inc., New York, NY, USA: Sanofi-Pasteur, Lyon, France; Serum Institute of India, Pune, India.

Abbreviations: MenA, meningococcus serogroup A; MenC, meningococcus serogroup C; TT, tetanus toxoid; DT, diphtheria toxin; Hib, hemophilus influenzae serotype b; CRM, corynebacterium diphtheriae toxin, cross-reactive material 197.

Table 3 MenACWY-TT product information

Manufacturer

GlaxoSmithKline, plc

Composition (one dose: 5 mL)

Neisseria meningitidis group A polysaccharide (5 micrograms)*

Neisseria meningitidis group C polysaccharide (5 micrograms)*

Neisseria meningitidis group W-135 polysaccharide (5 micrograms)*

Neisseria meningitidis group Y polysaccharide (5 micrograms)*

Pharmaceutical form

Powder and solvent for solution for intramuscular injection

Indications

Individuals from the age of 12 months and above

Licensure

Approved in Europe by the Committee for Medicinal Products for Human Use (CHMP) on February 16, 2012

Notes:

* Conjugated to tetanus toxoid carrier protein, 44 micrograms. Manufacturer details: GlaxoSmithKline plc, Brentford, UK.

Abbreviation: MenACWY-TT, serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine.

Table 4 Phase II and Phase III clinical vaccination trials of MenACWY-TT conjugate vaccine in infants, toddlers, and children

Phase	Author	Year	Age group	Country	Registry number at Clinicaltrials.gov
II	Klein et al^Citation89	2013	9–12 months	United States	NCT0471081
II	Vesikari et al^Citation90	2012	12–23 months 2–10 years	Finland Finland	NCT0427908
II	Knuf et al^Citation87	2010	12–14 months 3–5 years	Germany Austria	NCT0126984
II	Knuf et al^Citation88	2012	12–14 months 3–5 years	Germany Austria	NCT0126984
II	Dbaibo et al^Citation94	2012	4.5–10 years	Lebanon	NCT0661557
III	Ruiz-Palacios et al^Citation105	2013	12–23 months	Taiwan Mexico	NCT0758264
III	Vesikari et al^Citation91	2011	12–23 months	Finland	NCT0474266
III	Knuf et al^Citation106	2011	12–23 months	Austria Germany Greece	NCT0508261
III	Memish et al^Citation93	2011	2–10 years	Philippines India Lebanon Saudi Arabia	NCT0514904
III	Knuf et al^Citation95	2013	2–10 years	Germany France	NCT0674583

Abbreviation: MenACWY-TT, serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine.

Table 5 Phase II and phase III clinical vaccination trials of MenACWY-TT conjugate vaccine in adolescents and adults

Phase	Author	Year	Age group	Country	Registry number at Clinicaltrials.gov
II	Dbaibo et al^Citation94	2012	11–34 years	Lebanon	NCT0661557
II	Ostergaard et al^Citation99	2013	15–19 years	Denmark	NCT0390143
II	Baxter et al^Citation100	2011	10–25 years	USA	NCT0454909
II	Ostergaard et al^Citation96	2009	15–19 years 18–25 years	Belgium Denmark	NCT0126945 NCT0196950
II	Borja-Tabora et al^Citation98	2013	11–55 years	Philippines Saudi Arabia	NCT0356369
III	Ostergaard et al^Citation103	2012	11–17 years	Sweden Denmark	NCT0465816
III	Bermal et al^Citation97	2011	11–17 years	Philippines India Taiwan	NCT0464815
III	Dbaibo et al^Citation85	2012	18–55 years	Lebanon Philippines	NCT0453986
III	Aplasca-De Los Reyes et al^Citation104	2012	18–55 years	Lebanon Philippines	NCT0453986
III	Dbaibo et al^Citation46	2013	56–103 years	Lebanon	NCT1235975

Abbreviation: MenACWY-TT, serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine.

KleinNPBaineYBiancoVOne or two doses of quadrivalent meningococcal serogroups a, C, w-135 and y tetanus toxoid conjugate vaccine is immunogenic in 9- to 12-month-old childrenPediatr Infect Dis J201332776076723348814

 PubMed Web of Science ®Google Scholar

VesikariTForsténABoutriauDBiancoVVan der WielenMMillerJMRandomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlersHum Vaccin Immunother20128121892190323032159

 PubMed Web of Science ®Google Scholar

KnufMKieninger-BaumDHabermehlPA dose-range study assessing immunogenicity and safety of one dose of a new candidate meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered in the second year of life and in young childrenVaccine201028374475319887137

 PubMed Web of Science ®Google Scholar

KnufMBaineYBiancoVBoutriauDMillerJMAntibody persistence and immune memory 15 months after priming with an investigational tetravalent meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in toddlers and young childrenHum Vaccin Immunother20128786687222485049

 PubMed Web of Science ®Google Scholar

DbaiboGVan der WielenMRedaMThe tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic with a clinically acceptable safety profile in subjects previously vaccinated with a tetravalent polysaccharide vaccineInt J Infect Dis2012168e608e61522704725

 PubMed Web of Science ®Google Scholar

Ruiz-PalaciosGMHuangLMLinTYImmunogenicity and safety of a booster dose of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine coadministered with the tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers: a randomized trialPediatr Infect Dis J2013321627123076383

 PubMed Web of Science ®Google Scholar

VesikariTKarvonenABiancoVVan der WielenMMillerJTetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trialVaccine201129254274428421443965

 PubMed Web of Science ®Google Scholar

KnufMPantazi-ChatzikonstantinouAPfletschingerUAn investigational tetravalent meningococcal serogroups A, C, W-135 and Y-tetanus toxoid conjugate vaccine co-administered with Infanrix hexa is immunogenic, with an acceptable safety profile in 12–23-month-old childrenVaccine201129254264427321420417

 PubMed Web of Science ®Google Scholar

MemishZADbaiboGMontellanoMImmunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profilePediatr Infect Dis J2011304e56e6221278617

 PubMed Web of Science ®Google Scholar

KnufMRomainOKindlerKImmunogenicity and safety of the quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) in 2–10-year-old children: results of an open, randomised, controlled studyEur J Pediatr2013172560161223307281

 PubMed Web of Science ®Google Scholar

ØstergaardLVan der WielenMBiancoVMillerJMPersistence of antibodies for 42 months following vaccination of adolescents with a meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT)Int J Infect Dis2013173e173e17623246368

 PubMed Web of Science ®Google Scholar

BaxterRBaineYEnsorKBiancoVFriedlandLRMillerJMImmunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of agePediatr Infect Dis J2011303e41e4821200360

 PubMed Web of Science ®Google Scholar

OstergaardLLebacqEPoolmanJMaechlerGBoutriauDImmunogenicity, reactogenicity and persistence of meningococcal A, C, W-135 and Y-tetanus toxoid candidate conjugate (MenACWY-TT) vaccine formulations in adolescents aged 15–25 yearsVaccine200927116116818834910

 PubMed Web of Science ®Google Scholar

Borja-TaboraCMontalbanCMemishZAImmune response, antibody persistence, and safety of a single dose of the quadrivalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine in adolescents and adults: results of an open, randomised, controlled studyBMC Infect Dis20131311623510357

 PubMed Web of Science ®Google Scholar

ØstergaardLSilfverdalSABerglundJA tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11–17 years: an open, randomised, controlled trialVaccine201230477478322107850

 PubMed Web of Science ®Google Scholar

BermalNHuangLMDubeyAPSafety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adultsHum Vaccin20117223924721343698

 PubMed Web of Science ®Google Scholar

DbaiboGMacalaladNAplasca-De Los ReyesMRThe immunogenicity and safety of an investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) compared with a licensed meningococcal tetravalent polysaccharide vaccine: a randomized, controlled non-inferiority studyHum Vaccin Immunother20128787388022485050

 PubMed Web of Science ®Google Scholar

Aplasca-De Los ReyesMRDimaanoEMacalaladNThe investigational meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (ACWY-TT) and the seasonal influenza virus vaccine are immunogenic and well-tolerated when co-administered in adultsHum Vaccin Immunother20128788188722485048

 PubMed Web of Science ®Google Scholar

DbaiboGEl-AyoubiNGhanemSImmunogenicity and safety of a quadrivalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine (MenACWY-TT) administered to adults aged 56 Years and older: results of an open-label, randomized, controlled trialDrugs Aging201330530931923494214

 PubMed Web of Science ®Google Scholar