A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

CompletadoFase 3ClinicalTrials.gov

ID: NCT00474526Tipo: INTERVENTIONALInicio: 1 de mar de 2007Fin estimado: 1 de nov de 2009

Traducción no disponible, mostrando original

Resumen

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Elegibilidad

Edad mínima: 2 MonthsEdad máxima: 2 MonthsSexo: ALL

Criterios de inclusión

Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Criterios de exclusión

Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Intervenciones

biological

Meningococcal ACWY Conjugate Vaccine

biological

DTaP-IPV-HBV

biological

Hib

biological

Rotavirus

biological

Pneumococcal 7-valent Conjugate Vaccine

biological

HAV

biological

MMR-V

biological

DTaP

Ubicaciones

CEDEPAP Rio IV

Alvear 1439 PB Dpto, Rio IV, Cordoba, Córdoba Province, Argentina

Hospitales Materno Neonatal,

Castro Barros 650 - Barrio San Martin, Cordoba, Córdoba Province, Argentina

CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,

Córdoba, Córdoba Province, Argentina

Hospital Regional Luis Pasteur,

Mendoza N°2152, Villa Maria, Cordoba,, Córdoba Province, Argentina

Buenos Aires, Argentina

Centro Estudios Infect

Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,, Argentina

Patrocinadores

PrincipalNovartis Vaccines

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