Different Schedules of Meningococcal Vaccines in Infants

IMD : A Global Health Burden¹

Symptoms usually Progress Fast!

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

• 1 in 10 People who get it Die

Up to 1 in 5 Survivors suffer from Permanent Complications

• 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%).

MAT-AE-2200176-V1-Mar 2022