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Clinical Information Clinical Information Burden of meningococcal disease Serogroup distribution Nimenrix® immunogenicity Nimenrix® persistence Nimenrix® dose and administration Real-world impact Summary Important Safety Information Abbreviated Prescribing Information Support and Services Support and Services VideosWebinarsMaterialsSelf-detail Presentations

Nimenrix® immunogenicity

Infants from 6 weeks

MenACWY-TT vaccine can help to protect against A, C, W-135, and Y serogroups in infants aged 6 weeks in a 2+1 dosing schedule.2

  • Infants demonstrating protective immune response: 97.4%-100% after 2 priming doses; 98.4%-100% after a booster at 12 months
  • The response against group C was non-inferior to the one elicited by licensed MenC-CRM and MenC-TT vaccines in terms of percentages with rSBA titres ≥8 at 1 month after the second dose.*
The first dose was administered at 6 to 12 weeks of age, the second after an interval of 2 months, and a third (booster) dose administered at approximately 12 months of age.†2 

Adapted from Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine). [Local product document]. May 2022.

Infants from 6 months

MenACWY-TT vaccine can help to protect against A, C, W-135, and Y serogroups in infants aged 6 months in a 1+1 dosing schedule.2

Infants demonstrating protective immune response after a single dose at age 6 months: 93%– 99%; 99%–100% after a booster dose at age 15–18 months. Immunogenicity was not impacted by coadministration with other paediatric vaccines.2

Adapted from Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine). [Local product document]. May 2022.

Toddlers from 1 year

MenACWY-TT vaccine can help to protect toddlers aged 12–23 months against A, C, W-135, and Y serogroups with just one dose.‡2

Nimenrix® induced a protective immune response in toddlers against MenC that was comparable to the response induced by a monovalent MenC conjugate vaccine.2

Adapted from Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine). [Local product document]. May 2022.

 

Adolescents 11–17 years

MenACWY-TT vaccine can help to protect adolescents aged 11–17 years against A, C, W-135, and Y serogroups with just one dose.2

Nimenrix® induced a protective immune response comparable to other MenACWY vaccines.3

In clinical studies, with just one dose, participants achieved a consistently high level of seroprotection with Nimenrix®:

  • Exploratory analysis showed the proportion of subjects with hSBA titers ≥1:4 and ≥1:8 for serogroups A, W-135 and Y to be higher in the MenACWY-TT group than in the MenACWY-DT group.3
  • The immunogenicity of MenACYW-TT, as measured by hSBA vaccine seroresponse, was demonstrated to be noninferior to that of the licensed control MCV4-CRM. Additionally the percentage of participants achieving hSBA vaccine seroresponse, and seroprotection for each serogroup, 30 days after vaccination, was higher in the MenACYW-TT group than in the MCV4-CRM group.4

 
Adapted from Baxter R et al, 2011.

 
Adapted from Chang LJ et al, 2020.

Adults 18 years and above

MenACWY-TT vaccine can help to protect adults up to 56 years and older against serogroups A, C, W-135, and Y.5


 Adapted from Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine). [Local product document]. May 2022

 
Adapted from Dbaibo G et al, 2013.

At risk
MenACWY-TT vaccine shown to be immunogenic in patients with anatomic or functional asplenia.2
 


Nimenrix® will only confer protection against Neisseria meningitidis groups A, C, W-135 and Y. The vaccine will not protect against any other Neisseria meningitidis groups.

It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.

Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N meningitidis groups A, C, W-135, and Y even if they develop antibodies following vaccination with Nimenrix®.2
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*Bacterial antibody responses 21 to 48 days post-vaccination
†Study design: In clinical study MenACWY-TT-083, the first dose was administered at age 6–12 weeks, the second dose was given after an interval of 2 months, and a booster dose was given at the age of approximately 12 months. DTaP-HBV-IPV/ Hib and a 10-valent pneumococcal vaccine were coadministered.2
‡If a toddler (aged 12–23 months) is expected to be at particular risk of contracting invasive meningococcal disease due to exposure to groups W-135 and Y, consideration may be given to administering a second dose of Nimenrix® after an interval of 2 months.2
§Vaccine response defined as rSBA titres ≥32 for initially seronegative subjects or ≥4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive subjects (pre-vaccination rSBA titre ≥8)2


MenACWY-TT, Meningococcal serogroup A, C, W, and Y tetanus toxoid conjugate vaccine; MenC, Meningococcal serogroup C; MenC-CRM, Meningococcal serogroup C conjugate CRM197; MenC-TT, Meningococcal serogroup C tetanus toxoid conjugate vaccine; MenACWY-DT, Meningococcal serogroup A, C, W and Y diphtheria toxoid conjugate vaccine; MenACWY-CRM, Meningococcal serogroup A, C, W and Y conjugate CRM197 vaccine; hSBA, Human serum bacterial activity assay; rSBA, Rabbit serum bactericidal activity assay.

References:
  1. Stein-Zamir C, Shoob H, Sokolov I, Kunbar A, Abramson N, Zimmerman D. The clinical features and long-term sequelae of invasive meningococcal disease in children. Pediatr Infect Dis J. 2014;33(7):777-779.
  2. Nimenrix (Meningococcal group A, C, W-135 and Y conjugate vaccine). Egyptian Drug Authority leaflet approval date: 19/10/2022 Revision date: May 2022.
  3. Baxter R, Baine Y, Ensor K, Bianco V, Friedland LR, Miller JM. Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age. Pediatr Infect Dis J. 2011;30(3):e41-e48.
  4. Chang LJ, Hedrick J, Christensen S, Pan J, Jordanov E, Dhingra MS. A Phase II, randomized, immunogenicity and safety study of a quadrivalent meningococcal conjugate vaccine, MenACYW-TT, in healthy adolescents in the United States. Vaccine. 2020;38(19):3560-3569.
  5. Dbaibo G, El-Ayoubi N, Ghanem S, et al. Immunogenicity 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 trial. Drugs Aging. 2013;30(5):309-319.
Click here for Nimenrix® Prescribing Information Loading

Approval Code: BF0098OA686/052023
Invalidation date: 10/05/2025

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