A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00474487Tipo: INTERVENTIONALInicio: 1 de may de 2007Fin estimado: 1 de feb de 2008

Traducción no disponible, mostrando original

Resumen

This study will evaluate the safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Elegibilidad

Edad mínima: 19 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
individuals who are available for all visits and telephone calls scheduled for the study;
individuals who are in good health

Criterios de exclusión

individuals with a previous or suspected disease caused by N. meningitidis
individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
individuals with previous or suspected disease caused by N. meningitidis
individuals with any serious acute, chronic or progressive disease
individuals who are pregnant or breastfeeding

Intervenciones

biological

Meningococcal ACWY Polysaccharide Vaccine

One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.

biological

MenACWY CRM (19 to 55 years)

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.

biological

Meningococcal ACWY Conjugate Vaccine

One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.

biological

Novartis MenACWY Vaccine (56 to 65 Years)

One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Ubicaciones

Buenos Aires, Argentina

Patrocinadores

PrincipalNovartis Vaccines

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