Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers : a phase III randomised study
Invasive meningococcal disease has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomised study in toddlers aged 12-23 months evaluated the immunogenicity and safety of meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT), 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]; 6-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described up to 30 days post-vaccination. A total of 1183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT + MMR + V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT + DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT + PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR + V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:149 |
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| Enthalten in: |
Epidemiology and infection - 149(2021) vom: 05. Apr., Seite e90 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Dhingra, M S [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 09.08.2021 Date Revised 11.11.2023 published: Electronic ClinicalTrials.gov: NCT03205371 Citation Status MEDLINE |
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| doi: |
10.1017/S0950268821000698 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM323694926 |
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| 100 | 1 | |a Dhingra, M S |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers |b a phase III randomised study |
| 264 | 1 | |c 2021 | |
| 336 | |a Text |b txt |2 rdacontent | ||
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| 500 | |a Date Completed 09.08.2021 | ||
| 500 | |a Date Revised 11.11.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03205371 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Invasive meningococcal disease has high morbidity and mortality, with infants and young children among those at greatest risk. This phase III, open-label, randomised study in toddlers aged 12-23 months evaluated the immunogenicity and safety of meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT), 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]; 6-in-1 combination vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b [DTaP-IPV-HepB-Hib] and pneumococcal conjugate vaccine [PCV13])(NCT03205371). Immunogenicity to each meningococcal serogroup was assessed by serum bactericidal antibody assay using human complement (hSBA). Vaccine safety profiles were described up to 30 days post-vaccination. A total of 1183 participants were enrolled. The proportion with seroprotection (hSBA ≥1:8) to each meningococcal serogroup at Day 30 was comparable between the MenACYW-TT and MenACYW-TT + MMR + V groups (≥92 and ≥96%, respectively), between the MenACYW-TT and MenACYW-TT + DTaP-IPV-HepB-Hib groups (≥90% for both) and between the MenACYW-TT and MenACYW-TT + PCV13 groups (≥91 and ≥84%, respectively). The safety profiles of MenACYW-TT, and MMR + V, DTaP-IPV-HepB-Hib, and PCV13, with or without MenACYW-TT, were generally comparable. Coadministration of MenACYW-TT with paediatric vaccines in toddlers had no clinically relevant effect on the immunogenicity and safety of any of the vaccines | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Coadministration | |
| 650 | 4 | |a MenACYW-TT | |
| 650 | 4 | |a paediatric vaccines | |
| 650 | 4 | |a toddlers | |
| 650 | 7 | |a 13-valent pneumococcal vaccine |2 NLM | |
| 650 | 7 | |a Antibodies, Bacterial |2 NLM | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Chickenpox Vaccine |2 NLM | |
| 650 | 7 | |a Diphtheria-Tetanus-Pertussis Vaccine |2 NLM | |
| 650 | 7 | |a Haemophilus Vaccines |2 NLM | |
| 650 | 7 | |a Hepatitis B Vaccines |2 NLM | |
| 650 | 7 | |a Measles-Mumps-Rubella Vaccine |2 NLM | |
| 650 | 7 | |a Meningococcal Vaccines |2 NLM | |
| 650 | 7 | |a Pneumococcal Vaccines |2 NLM | |
| 650 | 7 | |a Poliovirus Vaccine, Inactivated |2 NLM | |
| 650 | 7 | |a Vaccines, Combined |2 NLM | |
| 650 | 7 | |a diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |2 NLM | |
| 650 | 7 | |a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine |2 NLM | |
| 700 | 1 | |a Namazova-Baranova, L |e verfasserin |4 aut | |
| 700 | 1 | |a Arredondo-Garcia, J L |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, K-H |e verfasserin |4 aut | |
| 700 | 1 | |a Limkittikul, K |e verfasserin |4 aut | |
| 700 | 1 | |a Jantarabenjakul, W |e verfasserin |4 aut | |
| 700 | 1 | |a Perminova, O |e verfasserin |4 aut | |
| 700 | 1 | |a Kobashi, I A R |e verfasserin |4 aut | |
| 700 | 1 | |a Bae, C-W |e verfasserin |4 aut | |
| 700 | 1 | |a Ojeda, J |e verfasserin |4 aut | |
| 700 | 1 | |a Park, J |e verfasserin |4 aut | |
| 700 | 1 | |a Chansinghakul, D |e verfasserin |4 aut | |
| 700 | 1 | |a B'Chir, S |e verfasserin |4 aut | |
| 700 | 1 | |a Neveu, D |e verfasserin |4 aut | |
| 700 | 1 | |a Bonaparte, M |e verfasserin |4 aut | |
| 700 | 1 | |a Jordanov, E |e verfasserin |4 aut | |
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| 773 | 1 | 8 | |g volume:149 |g year:2021 |g day:05 |g month:04 |g pages:e90 |
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