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Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

NCT ID: NCT00351923

Last Updated: 2008-10-13

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

PHASE3

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2006-12-31

Brief Summary

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This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.

Detailed Description

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Conditions

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Measles Mumps Rubella Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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MeMuRu-OKA (study vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Children must be healthy and have a birth weight \> 2000 g to participate

Exclusion Criteria

* confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
* Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
* Children must have received one dose (but not more) of MMR and of varicella at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days.
* Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol within 30 days before vaccination.
* Children must not have had measles, mumps, rubella or varicella/zoster, or have been exposed to those diseases within 30 days prior to study start.
* New-born infants (\< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child
Minimum Eligible Age

11 Months

Maximum Eligible Age

22 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Tauberbischofsheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Eschwege, Hesse, Germany

Site Status

GSK Investigational Site

Giessen, Hesse, Germany

Site Status

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

Site Status

Countries

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Germany

Other Identifiers

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106670

Identifier Type: -

Identifier Source: org_study_id