Safety of Combination of a Tetravalent Meningococcal Conjugate Vaccine Against Serogroups A, C, Y, W-135 With Other Vaccine Preparations: a Prospective Study of a Series of Cases Among Healthy Children and Children With Various Health Abnormalities
https://doi.org/10.15690/vsp.v16i2.1717
Abstract
Meningococcal infection is an acute disease caused by Neisseria meningitidis, which proceeds with a diverse clinical aspect from nasopharyngitis to meningococcal meningitis and meningococcemia. Since 2014, a tetravalent meningococcal conjugate vaccine has been registered in Russia. This vaccine creates protection against serogroups A, C, W-135, Y and can be used from the age of nine months to 55 years. The actual issue is a vaccine tolerability, including when combined with other vaccine preparations.
Objective: Our aim was to evaluate the safety of a tetravalent meningococcal conjugate vaccine against serogroups A, C, Y and W-135 when it is combined with other vaccine preparations.
Methods. A prospective full-design study assessed the tolerability of immunization with a meningococcal conjugate vaccine, both in case of monovaccination and in combination with a pneumococcal 13-valent conjugate vaccine, measles-mumps-rubella, viral hepatitis A, influenza, and chicken pox vaccines.
Results. 97 children aged from 9 months to 18 years were vaccinated, 20 of them were healthy and 77 had medical issues (with allergic pathology, ENT diseases, cardiovascular and nervous system diseases, lung diseases as well as orphan diseases). Among vaccinated children, general reactions were observed in 3/97 (3.1%) children, local reactions — in 5 (5.2%). The post-vaccination period passed asymptomatically and uneventfully in the prevailing majority of children vaccinated with a tetravalent meningococcal conjugate vaccine (in 91, 93.8%).
Conclusion. The immunization with a tetravalent meningococcal conjugate vaccine against serogroups A, C, Y, W-135 is well tolerated, both in case of monovaccination and in combination with other vaccine preparations, in healthy children of different age groups and in patients with different health status.
About the Authors
Leyla S. Namazova-BaranovaRussian Federation
Moscow
Daria A. Novikova
Russian Federation
Moscow
Marina V. Fedoseenko
Russian Federation
Moscow
Anna G. Gaivoronskaya
Russian Federation
Moscow
Natalia E. Tkachenko
Russian Federation
Moscow
Tatiana A. Kaljuzhnaya
Russian Federation
Moscow
Firuza Ch. Shakhtakhtinskaya
Russian Federation
Moscow
Marika I. Broeva
Russian Federation
Moscow
References
1. Устюгова Е.А., Никитюк Н.Ф., Обухов Ю.И., и др. Эпидемиологические аспекты менингококковой инфекции и вопросы вакцинопрофилактики // Инфекционные болезни. — 2016. — Т. 14. — № 1 — С. 55–64. [Ustyugova EА, Nikityuk NF, Obukhov YuI, et al. Epidemiological aspects of meningococcal infection and problems of vaccine prophylaxis. Infectious diseases. 2016;14(1): 55–64. (In Russ).] doi: 10.20953/1729-9225-2016-1-55-64.
2. Намазова-Баранова Л.С., Таточенко В.К., Алексина С.Г., и др. Вакцинация против гриппа, пневмококковой, менингококковой и HIB-инфекции часто болеющих детей // Педиатрическая фармакология. — 2007. — Т. 4. — № 1 — С. 67–81. [Namazova LS, Tatochenko VK, Aleksina SG, et al. Vaccination against flu, pneumococcal, meningococcal and HIB infection of the sickly children. Pediatric pharmacology. 2007;4(1):68–81. (In Russ).]
3. Кондратьева Е.И., Никонова В.С. Иммунизация больных с муковисцидозом // Педиатрия. Журнал им. Г.Н. Сперанского. — 2014. — Т. 93. — № 4 — С. 94–106. [Kondrat'eva EI, Nikonova VS. Immunizatsiya bol'nykh s mukovistsidozom. Pediatria. 2014;93(4):94–106. (In Russ).]
4. Ртищев А.Ю., Шамшева О.В. Проблема менингококковой инфекции у детей: пути решения // Детские инфекции. — 2009. — Т. 8. — № 3 — С. 31–35. [Rtishchev AYu, Shamsheva OV. The problem of prophylaxis of meningococcal disease at children: ways of the decision. Detskie infektsii. 2009;8(3):31–35. (In Russ).]
5. Pinal LM, Bassily E, Machmer A, et al. Safety and immunogenicity of a quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine in infants and toddlers: three multicenter phase III studies. Pediatr Infect Dis J. 2012;31(11):1173–1183. doi: 10.1097/INF.0b013e318268dfe4.
6. Королева И.С., Белошицкий Г.В., Закроева И.М., Коро лева М.А. Менингококковая инфекция в Российской Федерации // Эпидемиология и гигиена. Медицинский алфавит. — 2015. — Т. 1. — № 6 — С. 27–28. [Koroleva IS, Beloshitskii GV, Zakroeva IM, Koroleva MA. Meningokokkovaya infektsiya v Rossiiskoi Federatsii. Meditsinskii alfavit. 2015;1(6):27–28. (In Russ).]
7. Meningococcal vaccines: WHO position paper, November 2011. Wkly Epidemiol Rec. 2011;86(47):521–540.
8. Keyserling H, Papa T, Koranyi K, et al. Safety, immunogenicity and immune memory of a novel meningococcal (groups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine in healthy adolescents. Arch Pediatr Adolesc Med. 2005;159(10):907–913. doi: 10.1001/archpedi.159.10.907.
9. Yadav S, Manglani MV, Narayan DA, et al. Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-DT): a multicenter, open-label, non-randomized, phase III clinical trial. Indian Pediatr. 2014;51(6):451–456. doi: 10.1007/s13312-014-0435-7.
10. vaccineshoppecanada.com [Internet]. Menactra®. Product Monograph. Meningococcal (Group A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine. Toronto, Ontario, Canada: Sanofi Pasteur Limited; 2012 [cited 2017 Feb 12]. Available from: https://www.vaccineshoppecanada.com/document.cfm?file=menactra_e.pdf.
11. Клинические рекомендации по вакцинопрофилактике менингококковой инфекции / Под ред. Баранова А.А., НамазовойБарановой Л.С. — М.: ПедиатрЪ; 2016. — 36 с. [Klinicheskie rekomendatsii po vaktsinoprofilaktike meningokokkovoi infektsii. Ed by Baranov A.A., Namazova-Baranova L.S. Moscow: Pediatr»»; 2016. 36 p. (In Russ).]
Review
For citations:
Namazova-Baranova L.S., Novikova D.A., Fedoseenko M.V., Gaivoronskaya A.G., Tkachenko N.E., Kaljuzhnaya T.A., Shakhtakhtinskaya F.Ch., Broeva M.I. Safety of Combination of a Tetravalent Meningococcal Conjugate Vaccine Against Serogroups A, C, Y, W-135 With Other Vaccine Preparations: a Prospective Study of a Series of Cases Among Healthy Children and Children With Various Health Abnormalities. Current Pediatrics. 2017;16(2):156-162. https://doi.org/10.15690/vsp.v16i2.1717