Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b
Mem. Inst. Oswaldo Cruz
; 103(7): 711-718, Nov. 2008. ilus, tab
Artículo
en Inglés
| LILACS
| ID: lil-498381
Biblioteca responsable:
BR1.1
ABSTRACT
A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6 percent and 98.4 percent of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100 percent seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7 percent, 100 percent and 99.9 percent, respectively, for DTP/Hib-BM, three lots altogether and 99.2 percent, 100 percent and 100 percent for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Contexto en salud:
ODS3 - Salud y Bienestar
Problema de salud:
Meta 3.3: Poner fin a las enfermedades desatendidas y detener enfermedades transmisibles
Base de datos:
LILACS
Asunto principal:
Tétanos
/
Vacuna contra Difteria, Tétanos y Tos Ferina
/
Tos Ferina
/
Vacunas contra Haemophilus
/
Difteria
/
Infecciones por Haemophilus
Tipo de estudio:
Ensayo clínico controlado
Límite:
Femenino
/
Humanos
/
Lactante
/
Masculino
País/Región como asunto:
America del Sur
/
Brasil
Idioma:
Inglés
Revista:
Mem. Inst. Oswaldo Cruz
Asunto de la revista:
Medicina Tropical
/
Parasitología
Año:
2008
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Fiocruz/BR