L. S. Namazova-Baranova, O. Perminova, T. A. Romanova, V. Romanenko, A. Galustyan, V. Gorodin, I. Osipova, V. Rodnikova, S. Kharit, Y. Kovshirina, V. Anokhin, S. B'chir, D. Neveu, M. Bonaparte, G. Áñez, E. Jordanov, M. S. Dhingra, A. Goldstein
{"title":"四价脑膜炎球菌-破伤风类毒素结合疫苗(MenACYW -TT)与肺炎球菌结合疫苗在俄罗斯联邦健康幼儿中的免疫原性和安全性:一项III期随机研究","authors":"L. S. Namazova-Baranova, O. Perminova, T. A. Romanova, V. Romanenko, A. Galustyan, V. Gorodin, I. Osipova, V. Rodnikova, S. Kharit, Y. Kovshirina, V. Anokhin, S. B'chir, D. Neveu, M. Bonaparte, G. Áñez, E. Jordanov, M. S. Dhingra, A. Goldstein","doi":"10.31631/2073-3046-2022-21-6-65-81","DOIUrl":null,"url":null,"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.","PeriodicalId":11736,"journal":{"name":"Epidemiology and Vaccinal Prevention","volume":"15 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"L. S. Namazova-Baranova, O. Perminova, T. A. Romanova, V. Romanenko, A. Galustyan, V. Gorodin, I. Osipova, V. Rodnikova, S. Kharit, Y. Kovshirina, V. Anokhin, S. B'chir, D. Neveu, M. Bonaparte, G. Áñez, E. Jordanov, M. S. Dhingra, A. Goldstein\",\"doi\":\"10.31631/2073-3046-2022-21-6-65-81\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":11736,\"journal\":{\"name\":\"Epidemiology and Vaccinal Prevention\",\"volume\":\"15 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-01-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Epidemiology and Vaccinal Prevention\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.31631/2073-3046-2022-21-6-65-81\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Epidemiology and Vaccinal Prevention","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.31631/2073-3046-2022-21-6-65-81","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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
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.