Preview

Pediatric pharmacology

Advanced search

Protection against Meningococcal Infection from the First Months of Life and without Age Restrictions — the Response to Modern Epidemiological Challenges

https://doi.org/10.15690/pf.v22i4.2948

Abstract

Children with generalized form of meningococcal infection (GFMI) have a high risk of developing life-threatening conditions and fatal outcomes within 24 hours of the onset of the first symptoms, even with timely treatment. Children under the age of 5 contribute significantly to the mortality rate of GFMI, which is six times higher than the national mortality rate. Data from 2010 to 2022 show that 73% of all cases of GFMI in infants under 9 months of age occur before the age of 9 months. This highlights the need to shift the start of meningococcal vaccination to an earlier age, starting from 6 weeks of life. In the Russian Federation, the MenQuadfi vaccine (MenACWY-TT, Sanofi) is registered, which contains antigens of the most common meningococcal strains A, C, W, and Y. Modern molecular technologies were used in the development of the vaccine, which allowed for increased immunogenicity while maintaining a favorable safety profile, including when used in combination with vaccines against 15 infections, resulting in a rapid and pronounced response on days 6–7 after vaccination and revaccination, as well as an extended duration of immune protection of up to 7–10 years, with expanded age-related applicability for children from 6 weeks of age, adolescents, adults, and the elderly. The results of 23 international studies (including Russian studies) confirm that the new MenACWY-TT vaccine fully meets the criteria for selecting vaccines for routine immunization against meningococcal infection and can provide long-lasting effective protection against GFMI from an early age.

About the Authors

Mikhail P. Kostinov
Sechenov Moscow Medical Academy ; I.I. Mechnikov Scientific Research Institute of Vaccines and Serums
Russian Federation

MD, PhD, Professor 

5А, Malyi Kazennyi pereulok, Moscow, 105064, +7 (495) 741-35-23 


Disclosure of interest:

Not declared. 



Marina V. Fedoseenko
Research Institute of Pediatrics and Children’s Health in Petrovsky National Research Centre of Surgery ; Pirogov Russian National Research Medical University
Russian Federation

MD, PhD 


Disclosure of interest:

Not declared. 



References

1. Thompson MJ, Ninis N, Perera R, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397–403. doi: https://doi.org/10.1016/S0140-6736(06)67932-4

2. Olbrich KJ, Müller D, Schumacher S, et al. Systematic Review of Invasive Meningococcal Disease: Sequelae and Quality of Life Impact on Patients and Their Caregivers. Infect Dis Ther. 2018;7(4):421– 438. doi: https://doi.org/10.1007/s40121-018-0213-2

3. Shen J, Begum N, Ruiz-Garcia Y, et al. Range of invasive meningococcal disease sequelae and health economic application — a systematic and clinical review. BMC Public Health. 2022 May 31;22(1):1078. doi: https://doi.org/10.1186/s12889-022-13342-2

4. Davydenko MA, Churilova NS, Koroleva IS. Epidemiological Manifestations of Purulent Bacterial Meningitis in the Russian Federation. Epidemiology and Vaccinal Prevention. 2024;23(5):33– 41. (In Russ). doi: https://doi.org/10.31631/2073-3046-2024-23-5-33-41

5. Defeating meningitis by 2030: a global road map. Geneva: World Health Organization; 2021. 38 p. (In Russ). Доступно по: http://apps.who.int/iris/bitstream/handle/10665/342010/9789240030145-rus.pdf. Ссылка активна на 27.08.2025.

6. Resolution of the Chief State Sanitary Doctor of the Russian Federation dated January 28, 2021 No. 4 “Ob utverzhdenii sanitarnykh pravil i norm SanPiN 3.3686-21 “Sanitarnoepidemiologicheskie trebovaniya po profilaktike infektsionnykh boleznei”. (In Russ).

7. O sostoyanii sanitarno-epidemiologicheskogo blagopoluchiya naseleniya v Rossiiskoi Federatsii v 2022 godu: State report. Moscow: Federal Service for Supervision of Consumer Rights Protection and Human Welfare; 2023. 368 p. (In Russ).

8. Koroleva IS, Koroleva MA, Churilova NS, et al. Meningococcal infection in modern realities: a narrative review. Epidemiology and Infectious Diseases. Current Items = Èpidemiologiâ i Infekcionnye Bolezni. Aktual’nye voprosy. 2023;13(2):34–39. (In Russ). doi: https://doi.org/10.18565/epidem.2023.13.2.34-9

9. Koroleva MA, Gritsay MI, Churilova NS, Koroleva IS. Epidemiological Features of Purulent Bacterial Meningitis in the Russian Federation at the Present Stage. Epidemiology and Vaccinal Prevention. 2023;22(4):67–74. (In Russ). doi: https://doi.org/10.31631/2073-3046-2023-22-4-67-74

10. O sostoyanii sanitarnoepidemiologicheskogo blagopoluchiya naseleniya v Rossiiskoi Federatsii v 2024 godu: State report. Moscow: Federal Service for Supervision of Consumer Rights Protection and Human Welfare; 2025. 424 p. (In Russ).

11. Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor). Document No. 02/12660-2025-27 dated 03.07.2025 “Ob epidemiologicheskoi situatsii po meningokokkovoi infektsii”. (In Russ).

12. Meningokokkovaya infektsiya i gnoinye bakterial’nye meningity v Rossiiskoi Federatsii 2023 g.: Information and analytical review. Central Research Institute of Epidemiology of Rospotrebnadzor of the Russian Federation; 2024. (In Russ).

13. State Register of Medicines. (In Russ). Доступно по: grls.minzdrav.gov.ru. Ссылка активна на 10.06.2025.

14. Meningokokkovaya infektsiya i gnoinye bakterial’nye meningity v Rossiiskoi Federatsii: Information and analytical review. Central Research Institute of Epidemiology of Rospotrebnadzor of the Russian Federation; 2010–2022. (In Russ).

15. Order of the Ministry of Health of Russia dated December 06, 2021 No. 1122н “Ob utverzhdenii natsional’nogo kalendarya profilakticheskikh privivok, kalendarya profilakticheskikh privivok po epidemicheskim pokazaniyam i poryadka provedeniya profilakticheskikh privivok”. (In Russ).

16. Meningokokkovaya infektsiya u detei: Clinical guidelines. Ministry of Health of Russian Federation; 2023. 72 p. (In Russ).

17. O sostoyanii sanitarnoepidemiologicheskogo blagopoluchiya naseleniya v Rossiiskoi Federatsii v 2023 godu: State report. Moscow: Federal Service for Supervision of Consumer Rights Protection and Human Welfare; 2024. 364 p. (In Russ).

18. WHO. Vaccination schedule for Meningococcal disease Available online: https://immunizationdata.who.int/global/wiisedetail-page/vaccination-schedule-for-meningococcal-disease. Accessed on June 26, 2025

19. WHO. Enhanced surveillance of meningitis in Africa. Meningite belt countries dashboard WHO-AFRO. In: Microsoft Power BI. Available online: https://app.powerbi.com/view?r=eyJrIjoiMzExZTUzZDAtMmQ5Ni00YjkxLWFmZmItODljOWZhOTMyM2Y3IiwidCI6ImY2MTBjMGI3LWJkMjQtNGIzOS04MTBiLTNkYzI4MGFmYjU5MCIsImMiOjh9. Accessed on May 25, 2025.

20. Meningococcal vaccines: WHO position paper on the use of multivalent meningococcal conjugate vaccines in countries of the African meningitis belt. Wkly Epidemiol Rec. 2024;99(1/2):1–10.

21. Borrow R, Findlow J. The important lessons lurking in the history of meningococcal epidemiology. Expert Rev Vaccines. 2024;23(1):445–462. doi: https://doi.org/10.1080/14760584.2024.2329618

22. Cassiolato AP, Camargo CH, Piccoli Cecconi MC, et al. Genomic characterization of invasive meningococcal X isolates from Brazil, 1992–2022. Int Microbiol. 2023;26(3):611–618. doi: https://doi.org/10.1007/s10123-023-00325-5

23. Fazio C, Starnino S, Dal Soldà M, et al. Neisseria meningitidis serogroup X sequence type 2888, Italy. EmergInfect Dis. 2010;16(2):359–360. doi: https://doi.org/10.3201/eid1602.091553

24. Tanır G, Ozsurekci Y, Lucidarme J, et al. Neisseria meningitidis Serogroup X ST-5799 (ST-22 complex) in Turkey: A unique pediatric case. Hum Vaccin Immunother. 2018;14(1):209–212. doi: https://doi.org/10.1080/21645515.2017.1377380

25. Pan J, Yao P, Zhang H, et al. The case of a new sequence type 7 serogroup X Neisseria meningitidis infection in China: may capsular switching change serogroup profile? Int J Infect Dis. 2014:29:62– 64. doi: https://doi.org/10.1016/j.ijid.2014.07.022

26. Principles and considerations for adding a vaccine to a national immunization programme. Geneva: World Health Organization; 2014. Available online: https://iris.who.int/bitstream/handle/10665/111548/9789241506892_eng.pdf. Accessed on May 25, 2025.

27. Namazova-Baranova LS, Fedoseenko MV, Baranov AA. New Horizons of National Immunization Calendar. Voprosy sovremennoi pediatrii — Current Pediatrics. 2019;18(1):13–30. (In Russ). doi: https://doi.org/10.15690/vsp.v18i1.1988

28. Burchett HE, Mounier-Jack S, Griffiths UK, Mills AJ. National decision-making on adopting new vaccines: a systematic review. Health Policy Plan. 2012;27(Suppl 2):ii62–ii76. doi: https://doi.org/10.1093/heapol/czr049

29. Союз педиатров России. Календарь вакцинации. [The Union of Pediatricians of Russia. Vaccination calendar. (In Russ).] Доступно по: https://www.pediatr-russia.ru/parents_information/vaktsinatsiya/kalendar-vaktsinatsii/index.php. Ссылка активна на 13.06.2025.

30. Kostinov MP, Zverev VV, Svitich OA, Mukhachev IS. Vaccination of Persons Subject to Call-up for Military Service. Epidemiology and Vaccinal Prevention. 2023;22(5):58– 62. (In Russ). doi: https://doi.org/10.31631/2073-3046-2023-22-5-58-62

31. Vaktsinoprofilaktika lits, podlezhashchikh prizyvu i postupayushchikh po kontraktu na voennuyu sluzhbu: Guide for doctors. Kostinov MP, Zverev VV, Svitich OA, eds. Moscow: Gruppa MDV; 2024. 48 p. (In Russ).

32. Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Available online: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/generalrecs.pdf. Accessed on June 06, 2025.

33. Menactra. In: U.S. Food & Drug Administration: Official website. Available online: https://www.fda.gov/vaccines-blood-biologics/vaccines/menactra. Accessed on June 06, 2025.

34. General characteristics of the drug (vaccine) Menactra. Registration certificate ЛП-№(001763)-(РГ-RU) dated February 02, 2023. In: Register of general characteristics of medicinal products (GCHP) and package leaflets (PL) of the EAEU: Official website. (In Russ). Доступно по: https://lk.regmed.ru/Register/EAEU_SmPC. Ссылка активна на 28.08.2025.

35. Meningococcal vaccines: WHO position paper, November 2011. Wkly Epidemiol Rec. 2011;86(47):521–539.

36. Nimenrix: meningococcal groups A, C, W-135 and Y conjugate vaccine. In: European Medicines Agency (EMA): Official website. Available online: https://www.ema.europa.eu/en/medicines/human/EPAR/nimenrix. Accessed on June 10, 2025.

37. MenQuadfi. In: U.S. Food & Drug Administration: Official website. Available online: https://www.fda.gov/vaccines-blood-biologics/menquadfi. Accessed on June 10, 2025.

38. Pichichero ME. Protein carriers of conjugate vaccines: characteristics, development, and clinical trials. Hum Vaccin Immunother. 2013;9(12):2505–2523. doi: https://doi.org/10.4161/hv.26109

39. Khatun F, Stephenson RJ, Toth I. An Overview of Structural Features of Antibacterial Glycoconjugate Vaccines That Influence Their Immunogenicity. Chemistry. 2017:23(18):4233–4254. doi: https://doi.org/10.1002/chem.201603599

40. Fusco PC, Farley EK, Huang CH, et al. Protective meningococcal capsular polysaccharide epitopes and the role of O acetylation. Clin Vaccine Immunol. 2007;14(5):577–584. doi: https://doi.org/10.1128/CVI.00009-07

41. Bröker M, Berti F, Costantino P. Factors contributing to the immunogenicity of meningococcal conjugate vaccines. Hum Vaccin Immunother. 2016;12(7):1808–1824. doi: https://doi.org/10.1080/21645515.2016.1153206

42. General characteristics of the drug (vaccine) MenQuadfi. Registration certificate ЛП-№(001514)-(РГ-RU) dated December 07, 2022. In: Register of general characteristics of medicinal products (GCHP) and package leaflets (PL) of the EAEU: Official website. (In Russ). Доступно по: https://lk.regmed.ru/Register/EAEU_SmPC. Ссылка активна на 28.08.2025.

43. Coudeville, L., Bertrand-Gerentes, I., et al. Modeling antibody persistence after MenACYW-TT vaccination and comparative analysis with other quadrivalent meningococcal vaccines. Sci Rep 15, 24990 (2025). https://doi.org/10.1038/s41598-025-08112-0

44. National library of Medicine. ClinicalTrials.Gov. Available online: https://clinicaltrials.gov. Accessed on June 10, 2025.

45. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US. US ClinicalTrials.gov Identifier: NCT03537508 (MET42). In: ClinicalTrials. Gov: Website. Available online: https://clinicaltrials.gov/ct2/show/NCT03537508. Accessed on June 10, 2025.

46. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom. US ClinicalTrials.gov Identifier: NCT03632720 (MET52). In: ClinicalTrials.Gov: Website. Available online: https://clinicaltrials.gov/ct2/show/NCT03632720. Accessed on June 10, 2025.

47. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico (MET33). US ClinicalTrials.gov Identifier: NCT03630705 (MET33). In: ClinicalTrials.Gov: Website. Available online: https://clinicaltrials.gov/ct2/show/NCT03630705. Accessed on June 10, 2025.

48. Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers. US ClinicalTrials.gov Identifier: NCT03691610 (MET61). In: ClinicalTrials. Gov: Website. Available online: https://clinicaltrials.gov/ct2/show/NCT03691610. Accessed on June 10, 2025.

49. Vesikari T, Borrow R, Forsten A, et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACWY-TT) in healthy toddlers: a Phase II randomized study. Hum Vaccin Immunother. 2020;16(6):1306–1312. doi: https://doi.org/10.1080/21645515.2020.1733869

50. van der Vliet D, Vesikari T, Sandner B, et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACWY-TT) vs. a licensed quadrivalent meningococcal tetanus toxoidconjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study. Epidemiol Infect. 2021;149:e50. doi: https://doi.org/10.1017/S0950268821000261

51. Knuf M, Rämet M, Breinholt Stærke N, et al. Comparing the meningococcal serogroup C immune response elicited by a tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACWY- TT) versus a quadrivalent or monovalent C tetanus toxoid conjugate meningococcal vaccine in healthy meningococcal vaccine-naïve toddlers: A randomised, controlled trial. Hum Vaccin Immunother. 2022;18(5):2052657. doi: https://doi.org/10.1080/21645515.2022.2052657

52. Dhingra MS, Namazova-Baranova L, Arredondo-Garcia JL, et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study. Epidemiol Infect. 2021;149:e90. doi: https://doi.org/10.1017/S0950268821000698.

53. NamazovaBaranova LS, Perminova OA, Romanova TA, et al. Immunogenicity and Safety of a Quadrivalent Meningococcal Tetanus Toxoid — Conjugate Vaccine (MenACYW- TT) Administered Concomitantly with Pneumococcal Conjugate Vaccine in Healthy Toddlers in the Russian Federation: a Phase III Randomized Study. Epidemiology and Vaccinal Prevention. 2022;21(6):65–81. (In Russ). doi: https://doi.org/10.31631/2073-3046-2022-21-6-65-81

54. Baccarini CI, Simon MW, Brandon D, et al. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naïve Children 2-9 Years of Age: A Phase III, Randomized Study. Pediatr Infect Dis J. 2020;39(10):955–960. doi: https://doi.org/10.1097/INF.0000000000002832

55. Piazza FM, Virta M, Paassilta M, et al. Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine administered as a booster dose in children vaccinated against meningococcal disease 3 years earlier as toddlers: A Phase III, open-label, multi-center study. Hum Vaccin Immunother. 2022;18(1):1–10. doi: https://doi.org/10.1080/21645515.2021.1902701

56. Martinón-Torres F, Simko R, Ebert R, et al. Five-Year Immune Persistence of a Quadrivalent Meningococcal Conjugate Vaccine (MenACWY-TT) and Immunogenicity and Safety of a Booster Dose in Children. Infect Dis Ther. 2025;14(5):991–1010. doi: https://doi.org/10.1007/s40121-025-01121-6

57. Díez-Domingo J, Simkó R, Icardi G, et al. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study. Infect Dis Ther. 2024;13(8):1835–1859. doi: https://doi.org/10.1007/s40121-024-01009-x

58. Áñez G, Hedrick J, Simon MW, et al. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoidconjugate vaccine (MenACWY-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother. 2020;16(6):1292– 1298. doi: https://doi.org/10.1080/21645515.2020.173386

59. Zambrano B, Peterson J, Deseda C, et al. Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study. Pediatr Res. 2023;94(3):1035–1043. doi: https://doi.org/10.1038/s41390-023-02478-5

60. Robertson CA, Jacqmein J, Selmani A, et al. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACWYTT) administered as a booster to adults aged ≥59 years: A phase III randomized study. Hum Vaccin Immunother. 2023;19(1):2160600. doi: https://doi.org/10.1080/21645515.2022.2160600

61. Pokrovskii VV, Yurin OG, Kravchenko AV, et al. Rekomendatsii po lecheniyu VICh-infektsii i svyazannykh s nei zabolevanii, khimioprofilaktike zarazheniya VICh. Epidemiology and Infectious Diseases. Current Items. 2022;12(S4):3–107. (In Russ).

62. WHO. WHO recommendations for routine immunization — summary tables. 2024. In: World Health Organization: Official website. Available online: https://www.who.int/teams/immunizationvaccines-and-biologicals/policies/who-recommendations-forroutine-immunization---summary-tables. Accessed on May 10, 2025.

63. Metodicheskie rekomendatsii po vyyavleniyu, rassledovaniyu i profilaktike pobochnykh proyavlenii posle immunizatsii. Moscow: Ministry of Health of Russian Federation; 2019. 56 p. (In Russ).

64. Organizatsiya palomnichestva v Saudovskuyu Araviyu: poryadok i aktual’nye voprosy. In: Ministry of Foreign Affairs of the Russian Federation: Official website. (In Russ). Доступно по: https://mid.ru/ru/foreign_policy/economic_diplomacy/vnesneekonomiceskie-svazisub-ektov-rossijskoj-federacii/1578429. Ссылка активна на 28.03.2025.

65. De Coster I, Fournie X, Faure C, et al. Assessment of preparation time with fully-liquid versus non-fully liquid paediatric hexavalent vaccines. A time and motion study. Vaccine. 2015;33(32):3976–3982. doi: https://doi.org/10.1016/j.vaccine.2015.06.030.


Review

For citations:


Kostinov M.P., Fedoseenko M.V. Protection against Meningococcal Infection from the First Months of Life and without Age Restrictions — the Response to Modern Epidemiological Challenges. Pediatric pharmacology. 2025;22(4):406-418. (In Russ.) https://doi.org/10.15690/pf.v22i4.2948

Views: 18


ISSN 1727-5776 (Print)
ISSN 2500-3089 (Online)