Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine.
Vaccine
; 29(16): 2947-55, 2011 Apr 05.
Article
en En
| MEDLINE
| ID: mdl-21335032
ABSTRACT
13-valent pneumococcal conjugate vaccine (PCV13) includes polysaccharide conjugates from six pneumococcal serotypes in addition to those in the licensed 7-valent vaccine, thereby offering expanded protection against pneumococcal disease. The phase 3 trial reported here was conducted per a regulatory requirement to evaluate the immunogenicity, safety, and tolerability of two lots of the final PCV13 formulation that differed with respect to production scale but not the manufacturing process. The anti-pneumococcal polysaccharide immunogenicity and safety/tolerability were found to be similar between the two PCV13 vaccine lots.
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Infecciones Neumocócicas
/
Vacunas Neumococicas
Tipo de estudio:
Clinical_trials
Límite:
Female
/
Humans
/
Infant
/
Male
País/Región como asunto:
Europa
Idioma:
En
Revista:
Vaccine
Año:
2011
Tipo del documento:
Article
País de afiliación:
Polonia