IMD : A Global Health Burden1


High fever, headache, stiff neck, confusion, nausea, vomiting, exhaustion, purplish rash, and death can happen in 1–2 days.



  • Brain Damage
  • Kidney Damage
  • Deafness Limb loss

170,000 Deaths worldwide

Schedule 3+1 and 2+1 Immunogenicity Data:

The percentage of subjects with hSBA titers ≥8 (95% CI) against Neisseria meningitidis serogroups A, C, W and Y immediately before the dose administered at 12 months of age (had been declines), by group.2

Schedule 3+1 and 2+1 Immunogenicity Data, European Medicines Agency 2013 Concern

During the evaluation, the CHMP had concern over the data provided by the company in children less than 2 years of age.3-4

Data showed a fall in antibodies between the third and fourth dose which could result in children lacking protection between 6 months and 1 year of age.

“The CHMP* concluded that the data provided were insufficient to extend the use of MenACWY-CRMto infants aged 2 to 23 months”

Schedule 1 Dose at 12-month Immunogenicity Data

Persistence of MenACWY-TT, Immune Response In Toddlers, aged 12-23 Months (After 2 Years)5

rSBAand hSBA antibody persistence 2 years after vaccination with MenACWY-TT at 12–23 months of age

For Serogroup A using hSBA ≥ 8, persistence was found to be dropped to 23%

Schedule 1 dose at 12-month wanning concern: MenACWY-TT Summary of Product Characteristics –Persistence Of Serum Bactericidal Antibody Titers Against MenA1

Special warnings and precautions for use6

“Studies with MenACWY-TT have shown a waning of serum bactericidal antibody titers against MenAwhen using human complement in theassay (hSBA)”1

"However, if an individual is expected to be at particular risk of exposure to MenAand received a dose of MenACWY-TT more than approximately one year previously, consideration may be given to administering a booster dose.”6

Schedule 1+1 Immunogenicity Data

Vaccine had a high immune response for all the different schedules, at ages 9 and 12 months, 9 and 15 months, or 12 and 15 months

Schedule 1+1 effectiveness data: MOH reported cases before and after mandatory MCV4 vaccination

Between 1995 and 2011: 

  • National surveillance data indicate that 1103 IMD cases were reported in KSA: 60% in 2000–2001, involving two (mainly MenW) outbreaks involving KSA citizens/residents and pilgrims focused inMecca and Medina.

Between 2012 and 2019,

  • 44 IMD cases were reported, all in KSA citizens/residents, and chiefly in children or infants.
  • No pilgrimage associated outbreaks have occurred since 2001.
  • Serogroup data were available for 62.5% of all cases for 2002–2011; MenW(40.0%), MenA (35.7%), and MenB (16.5%).
    1. CDC Meningococcal Disease, available at, accessed on16/2/2022.
    2. Stan L. Block, Julie Shepard, Hartley Garfield, Fang Xie, Linda Han, Peter M. Dull, and Igor Smolenov. Pediatr Infect Dis J2016;35:e48–e59.
    3. EMA/253316/2013. Questions and answers on the outcome of application to extend use of Menveo in children less than 2 years. 25April 2013.
    4. Jessica R. MacNeil. Use of MenACWY-CRM Vaccine in Children Aged 2 Through 23 Months at Increased Risk for MeningococcalDisease: Recommendations of the Advisory Committee on Immunization Practices, 2013. MMWR 63(24). 2014.
    5. Timo Vesikari, Aino Forsten, Veronique Bianco, Marie Van der Wielen, Jacqueline M. Miller. Trials in Vaccinology 3 (2014) 121–126.
    6. GSK. MenACWY- TT [SmPC]. EMA, Accessed August 2015
    7. Clinical trials. (2014). Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months ofAge. [online] Available at: [Accessed 1 February 2021].
    8. 2021 Infect Dis Ther,

MAT-AE-2200176-V1-Mar 2022