Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naïve Children 2–9 Years of Age: A Phase III, Randomized Study
| Autor: | Shane Christensen, Donald Brandon, Mandeep S. Dhingra, Emilia Jordanov, Carmen Baccarini, Michael W. Simon |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty MenACWY-CRM Population Meningococcal Vaccines Meningococcal vaccine Neisseria meningitidis 03 medical and health sciences 0302 clinical medicine Immunogenicity Vaccine Double-Blind Method children Conjugate vaccine 030225 pediatrics Internal medicine medicine Tetanus Toxoid Humans 030212 general & internal medicine Vaccines Combined education Child education.field_of_study Vaccines Conjugate Tetanus business.industry Diphtheria Puerto Rico Vaccination invasive meningococcal disease Toxoid Drugs Investigational MenACYW-TT medicine.disease Antibodies Bacterial United States Vaccine Reports Meningococcal Infections Infectious Diseases meningococcal vaccination noninferiority Child Preschool Pediatrics Perinatology and Child Health ComputingMethodologies_DOCUMENTANDTEXTPROCESSING conjugate vaccine business Meningitis |
| Zdroj: | The Pediatric Infectious Disease Journal |
| ISSN: | 1532-0987 0891-3668 0307-7438 |
| Popis: | Supplemental Digital Content is available in the text. Background: Invasive meningococcal disease is a major cause of meningitis in children. An investigational meningococcal (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW-TT) could offer protection against invasive meningococcal disease in this population. This phase III study assessed the immunogenicity and safety of MenACYW-TT in children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM197 (MenACWY-CRM). Methods: Healthy children 2–9 years of age in the United States, including Puerto Rico, were randomized (1:1) to receive MenACYW-TT (n = 499) or MenACWY-CRM (n = 501) (NCT03077438). Meningococcal antibody titers to the 4 vaccine serogroups were measured using a serum bactericidal antibody assay with human complement (hSBA) before and at day 30 after vaccination. Noninferiority between the vaccine groups was assessed by comparing seroresponse rates (postvaccination titers ≥1:16 when prevaccination titers were |
| Databáze: | OpenAIRE |
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