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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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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(Ad+)

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

Group Type EXPERIMENTAL

MenACWY-CRM conjugate vaccine, adjuvanted

Intervention Type BIOLOGICAL

MenACWY-CRM(Ad-)

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

Group Type EXPERIMENTAL

MenACWY-CRM conjugate vaccine, unadjuvanted

Intervention Type BIOLOGICAL

MenACWY- PS

Subjects received one single dose of the polysaccharide vaccine.

Group Type ACTIVE_COMPARATOR

MenACWY polysaccharide vaccine

Intervention Type BIOLOGICAL

Interventions

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MenACWY-CRM conjugate vaccine, adjuvanted

Intervention Type BIOLOGICAL

MenACWY-CRM conjugate vaccine, unadjuvanted

Intervention Type BIOLOGICAL

MenACWY polysaccharide vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No