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

Novartis

Status and phase: Completed; Phase 2

Conditions: Prevention of Meningococcal Disease

Treatments: Biological: MenACWY-CRM Vaccine; Biological: MenACWY-PS Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00262028

V59P8

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years

Enrollment: 910 patients

Sex: All

Ages: 12 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Group 1: Healthy children 2-10 years of age;
• Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Exclusion criteria

• Group 1: 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.
• Group 2: 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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910 participants in 5 patient groups

MenACWY-CRM (2-10 years)

Experimental group

Description:

Subjects received one dose of investigational MenACWY-CRM conjugate vaccine

Treatment:

Biological: MenACWY-CRM Vaccine

MenACWY-CRM (12-23 months)

Experimental group

Description:

Subjects received one dose of investigational MenACWY-CRM conjugate vaccine

Treatment:

Biological: MenACWY-CRM Vaccine

MenACWY-PS (2-10 years)

Active Comparator group

Description:

Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine

Treatment:

Biological: MenACWY-PS Vaccine

MenACWY-CRM+PnC (12-15 months)

Experimental group

Description:

Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC

Treatment:

Biological: MenACWY-CRM Vaccine

MenACWY-CRM+DTaP (16-23 months)

Experimental group

Description:

Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP

Treatment:

Biological: MenACWY-CRM Vaccine