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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

https://doi.org/10.31631/2073-3046-2022-21-6-65-81

Abstract

Relevance. Invasive meningococcal disease (IMD) has high morbidity and mortality, with infants and young children among those at greatest risk.

Materials & Methods. A phase III, open-­label, randomized study in toddlers aged 12–23 months evaluated the immunogenicity and safety of MenACYW­TT, a tetanus toxoid conjugated vaccine against meningococcal serogroups A, C, W, and Y, when coadministered with paediatric vaccines (measles, mumps and rubella [MMR]; varicella [V] in South Korea and Thailand; 6­in­1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP­IPVHepB­Hib] in Mexico and pneumococcal conjugate vaccine [PCV13]) in the Russian Federation (NCT03205371). This manuscript reports the outcome of the part of the study conducted in the Russian Federation using PCV13 as the co­administered vaccine. Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA) and, for a subset of subjects, baby rabbit complement (rSBA). Vaccine safety profiles were described up to 30 days postvaccination.

Results. A total of 1,183 participants were enrolled in the study, out of which 400 were from the Russian Federation. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW­-TT and MenACYW-­TT + PCV13 groups (≥91% and ≥84%, respectively). The safety profiles of MenACYW­-TT and PCV13, when given alone or concomitantly, were generally comparable.

Conclusion. Coadministration of MenACYW­-TT with pneumococcal conjugate vaccine in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines.

About the Authors

L. S. Namazova­-Baranova
Institute of Pediatrics, Central Clinical Hospital, Russian Academy of Science
Russian Federation

Moscow



O. A. Perminova
Children’s City Outpatient Clinic No. 5
Russian Federation

Perm



T. A. Romanova
Samara Regional Children’s Hospital
Russian Federation

Samara



V. V. Romanenko
Ural State Medical University
Russian Federation

Ekaterinburg



A. N. Galustyan
Saint­-Petersburg State Pediatric Medical University; Medical Technologies LTD
Russian Federation

St. Petersburg



V. N. Gorodin
Krasnodar State Medical University
Russian Federation

Krasnodar



I. V. Osipova
Altai State Medical University; LLC ASKO­MED­PLUS (Institution)
Russian Federation

Barnaul



V. Yu. Rodnikova
Gubernsky Lekar Outpatient Clinic
Russian Federation

Murmansk



S. M. Kharit
Pediatric Research and Clinical Center for Infection Diseases
Russian Federation

Saint Petersburg



Yu. V. Kovshirina
Siberian State Medical University
Russian Federation

Tomsk



V. А. Anokhin
Kazan State Medical University
Russian Federation

Kazan



S. B’Chir
Global Biostatistical Sciences
France

Sanofi, Marcy l’Etoile



D. Neveu
Global Pharmacovigilance
United States

Sanofi, Swiftwater, PA



M. Bonaparte
Global Clinical Immunology
United States

Sanofi, Swiftwater, PA



G. Áñez
Global Clinical Development Strategy
United States

Sanofi, Swiftwater, PA



E. Jordanov
Global Clinical Development Strategy
United States

Sanofi, Swiftwater, PA



M. S. Dhingra
Global Clinical Development Strategy
United States

Sanofi, Swiftwater, PA



A. V. Goldstein
Medical Affairs Sanofi
Russian Federation

Moscow



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Review

For citations:


Namazova­-Baranova L.S., Perminova O.A., Romanova T.A., Romanenko V.V., Galustyan A.N., Gorodin V.N., Osipova I.V., Rodnikova V.Yu., Kharit S.M., Kovshirina Yu.V., Anokhin V.А., B’Chir S., Neveu D., Bonaparte M., Áñez G., Jordanov E., Dhingra M.S., Goldstein A.V. 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.) https://doi.org/10.31631/2073-3046-2022-21-6-65-81

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ISSN 2073-3046 (Print)
ISSN 2619-0494 (Online)