Immunogenicity & Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

478 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2003-06-30

Brief Summary

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The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given, using either a 0-2-4 month or a 0-1-6 month schedule, to healthy adolescents aged 12-18 years; a control group will receive 2 doses of Havrix™ (0-6 months) and Meningitec™ (month 1).

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Detailed Description

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The study is open; however, vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner. 3 blood samplings for antibody testing: before vaccination and one month after the second and third vaccine doses.

Conditions

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Infections, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Meningococcal serogroup B vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy males or females between, and including, 12 and 18 years of age at the time of the first vaccination.
* Female subjects must be of non-childbearing potential.

Exclusion Criteria

* Previous vaccination against or history of meningococcal B or C, or hepatitis A disease or exposure to meningococcal B disease within last year.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* Family history of congenital or hereditary immunodeficiency.
* History of any neurologic disorders or seizures.

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes