Comparative Assessment of a Single Dose and a 2-dose Vaccination Series of a Quadrivalent Meningococcal CRM-conjugate Vaccine (MenACWY-CRM) in Children 2-10 Years of Age.
Pediatr Infect Dis J
; 35(1): e19-27, 2016 01.
Article
en En
| MEDLINE
| ID: mdl-26398741
ABSTRACT
BACKGROUND:
We compared the immunogenicity, safety and 1-year antibody persistence of a single-dose and a 2-dose series of a licensed meningococcal ACWY-CRM conjugate vaccine (MenACWY-CRM) in 2- to 10-year-old children.METHODS:
In this phase III, multicenter, observer-blind study, children aged 2-5 years (n = 359) and 6-10 years (n = 356) were randomized 11 to receive 2 doses of MenACWY-CRM (ACWY2) or 1 dose of placebo followed by 1 dose of MenACWY-CRM (ACWY1), 2 months apart. Immunogenicity was measured using serum bactericidal activity with human complement (hSBA). Primary outcomes were to assess the immunologic noninferiority and superiority of ACWY2 versus ACWY1.RESULTS:
One-month after the second dose, the hSBA seroresponse in ACWY2 was noninferior to ACWY1 for all 4 serogroups, in both age cohorts, and was superior for serogroups C and Y in the 2- to 5-year-old age cohort and for serogroup Y in the 6- to 10-year-old age cohort. Overall, 90%-99% of subjects in ACWY2 and 65%-96% in ACWY1 had hSBA titers ≥ 8; geometric mean titers were 1.8- to 6.4-fold higher in ACWY2 than ACWY1 across serogroups. At 1 year postvaccination, geometric mean titers declined, and the differences between ACWY2 and ACWY1 remained significant for serogroups A and C in the 2- to 5-year-old age cohort and for serogroups C and Y in the 6- to 10-year-old age cohort. The safety profile of MenACWY-CRM was similar in both groups.CONCLUSIONS:
The single dose and 2-dose MenACWY-CRM series were immunogenic and well tolerated. Although antibody responses were greater after 2 doses, especially in the 2- to 5-year-old age cohort, this difference was less pronounced at 1 year postvaccination.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
/
2_ODS3
/
3_ND
/
4_TD
Problema de salud:
1_medicamentos_vacinas_tecnologias
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2_enfermedades_transmissibles
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3_zoonosis
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4_meningitis
Asunto principal:
Vacunación
/
Vacunas Meningococicas
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Infecciones Meningocócicas
/
Neisseria meningitidis
Tipo de estudio:
Clinical_trials
Límite:
Child
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Child, preschool
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Female
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Humans
/
Male
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Pediatr Infect Dis J
Asunto de la revista:
DOENCAS TRANSMISSIVEIS
/
PEDIATRIA
Año:
2016
Tipo del documento:
Article
País de afiliación:
Países Bajos