A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Meningitis; Meningococcal Infections

Treatments: Biological: MenACWY CRM; Biological: Meningococcal ACWY Conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450437

V59P13

Details and patient eligibility

About

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

Enrollment: 3,539 patients

Sex: All

Ages: 11 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Exclusion criteria

• Subjects with a previous or suspected disease caused by N. meningitidis
• previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• previous or suspected disease caused by N. meningitidis
• Any serious acute, chronic or progressive disease
• Pregnant or breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,539 participants in 2 patient groups

Licensed Meningococcal Vaccine

Active Comparator group

Description:

Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine

Treatment:

Biological: Meningococcal ACWY Conjugate vaccine

Novartis MenACWY Conjugate Vaccine

Experimental group

Description:

Novartis meningococcal ACWY conjugate Vaccine

Treatment:

Biological: MenACWY CRM