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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

910 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Prevention of Meningococcal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Study Groups

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MenACWY-CRM (2-10 years)

Subjects received one dose of investigational MenACWY-CRM conjugate vaccine

Group Type EXPERIMENTAL

MenACWY-CRM Vaccine

Intervention Type BIOLOGICAL

MenACWY-CRM (12-23 months)

Subjects received one dose of investigational MenACWY-CRM conjugate vaccine

Group Type EXPERIMENTAL

MenACWY-CRM Vaccine

Intervention Type BIOLOGICAL

MenACWY-PS (2-10 years)

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

Group Type ACTIVE_COMPARATOR

MenACWY-PS Vaccine

Intervention Type BIOLOGICAL

MenACWY-CRM+PnC (12-15 months)

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

Group Type EXPERIMENTAL

MenACWY-CRM Vaccine

Intervention Type BIOLOGICAL

MenACWY-CRM+DTaP (16-23 months)

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

Group Type EXPERIMENTAL

MenACWY-CRM Vaccine

Intervention Type BIOLOGICAL

Interventions

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MenACWY-CRM Vaccine

Intervention Type BIOLOGICAL

MenACWY-PS Vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No