A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Meningitis; Meningococcal Infections

Treatments: Biological: Meningococcal ACWY Polysaccharide Vaccine; Biological: MenACWY CRM (19 to 55 years); Biological: Meningococcal ACWY Conjugate Vaccine; Biological: Novartis MenACWY Vaccine (56 to 65 Years)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00474487

V59P17

Details and patient eligibility

About

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

Enrollment: 2,831 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,831 participants in 4 patient groups

Novartis MenACWY Vaccine (19 to 55 Years)

Experimental group

Description:

Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years

Treatment:

Biological: MenACWY CRM (19 to 55 years)

Licensed polysaccharide vaccine

Active Comparator group

Description:

Licensed meningococcal ACWY polysaccharide vaccine

Treatment:

Biological: Meningococcal ACWY Polysaccharide Vaccine

Licensed Conjugate Vaccine

Active Comparator group

Description:

Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine

Treatment:

Biological: Meningococcal ACWY Conjugate Vaccine

Novartis MenACWY Vaccine (56 to 65 Years)

Experimental group

Description:

Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Treatment:

Biological: Novartis MenACWY Vaccine (56 to 65 Years)