Assess the Non-inferiority of GSK Biologicals' Mencevax™ ACWY (Manufactured by a New Process) vs Mencevax™ ACWY (the Already Existing Vaccine in the Market) When Given as a Single Dose to Subjects Aged 2-30 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

PHASE4

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-11-30

Brief Summary

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The purpose of this study is to evaluate that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax™ ACWY vaccine in terms of immunogenicity, safety and reactogenicity, in healthy subjects aged 2-30 years.

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Detailed Description

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"Randomized study with four groups to receive one of the following vaccination regimens: - One of the 3 lots of GSK Biologicals' Mencevax™ ACWY vaccine manufactured by the new process (3 different groups) - GSK Biologicals' already existing Mencevax™ ACWY

Conditions

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Infections, Meningococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Mencevax ACWY

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female between 2 and 30 years of age at the time of vaccination.
* If the subject is female, she must be of non-childbearing potential. If a subject is a female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of study vaccine, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Vaccination with a meningococcal vaccine within the last five years.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 15 days before vaccine administration and ending 30 days after.
* History of or known exposure to meningococcal serogroup A, C, W135 or Y disease or contacts with subjects who had meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Minimum Eligible Age

2 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Study Documents

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