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
Externí odkaz: