Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study
Journal of Korean Medical Science
; : e100-2018.
Artículo
en Inglés
| WPRIM (Pacífico Occidental)
| ID: wpr-713706
Biblioteca responsable:
WPRO
ABSTRACT
BACKGROUND:
The frequency with which the 2 B lineages have been found to cocirculate in a season has been on the rise, which has spurred the need for a quadrivalent influenza vaccine (QIV) to protect against both B lineages. The World Health Organization (WHO) recommended that QIV include both B lineages beginning in the 2013–2014 flu season. This study was conducted to evaluate the immunogenicity and safety of an egg-cultivated QIV in healthy Korean children and adolescents aged ≥ 6 months to < 19 years.METHODS:
A total of 528 subjects were randomized 41 to receive either a QIV (GC3110A) or a trivalent influenza vaccine. Hemagglutination inhibition antibody responses were assessed 28 days after the last dose. Safety was also evaluated.RESULTS:
The proportion of subjects in the GC3110A group who achieved seroconversion was confirmed to exceed 40% across all age groups. The proportion of subjects aged ≥ 6 months to < 3 years in the GC3110A group who achieved seroprotection failed to meet the Ministry of Food and Drug Safety (MFDS) standard of 70%. Potential causes may include the small number of subjects, as well as the small dosage. However, results pertaining to the other age groups satisfied the MFDS standard. The safety profile was also comparable to that of the control.CONCLUSION:
The new quadrivalent split influenza vaccine may offer broader protection to children and adolescents aged ≥ 3 years to < 19 years of age against both influenza B lineages than the existing trivalent influenza vaccines (Registered at the ClinicalTrials.gov NCT02541253).
Texto completo:
Disponible
Contexto en salud:
Agenda de Salud Sostenible para las Américas
/
ODS3 - Salud y Bienestar
Problema de salud:
Objetivo 9: Enfermedades no transmisibles y salud mental
/
Objetivo 10: Enfermedades transmisibles
/
Meta 3.8: Alcanzar cobertura universal de salud
/
Meta 3.3: Poner fin a las enfermedades desatendidas y detener enfermedades transmisibles
/
Meta 3.4: Reducir las muertes prematuras por enfermedades no transmisibles
Base de datos:
WPRIM (Pacífico Occidental)
Asunto principal:
Estaciones del Año
/
Organización Mundial de la Salud
/
Vacunas contra la Influenza
/
Gripe Humana
/
Seroconversión
/
Hemaglutinación
/
Formación de Anticuerpos
Tipo de estudio:
Ensayo clínico controlado
Límite:
Adolescente
/
Niño
/
Humanos
Idioma:
Inglés
Revista:
Journal of Korean Medical Science
Año:
2018
Tipo del documento:
Artículo