Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Novartis

Status and phase: Completed; Phase 2

Conditions: Prevention of Meningococcal Disease

Treatments: Biological: MenACWY polysaccharide vaccine; Biological: MenACWY-CRM conjugate vaccine, unadjuvanted; Biological: MenACWY-CRM conjugate vaccine, adjuvanted

Study type: Interventional

Funder types: Industry

Identifiers

NCT00262041

BB-IND 11278

V59P6

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Enrollment: 524 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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524 participants in 3 patient groups

MenACWY-CRM(Ad+)

Experimental group

Description:

Subjects received one single dose of adjuvanted formulation of conjugate vaccine.

Treatment:

Biological: MenACWY-CRM conjugate vaccine, adjuvanted

MenACWY-CRM(Ad-)

Experimental group

Description:

Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.

Treatment:

Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

MenACWY- PS

Active Comparator group

Description:

Subjects received one single dose of the polysaccharide vaccine.

Treatment:

Biological: MenACWY polysaccharide vaccine