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Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

Last Updated: 2016-09-26

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

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-06-30

Brief Summary

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This is a study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals combined measles-mumps-rubella varicella candidate vaccine given to healthy children in their second year of life.

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Detailed Description

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This study included an active control group who received the licensed Priorix (measles, mumps, rubella \[MMR\] vaccine).

Conditions

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Measles Rubella Mumps 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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Measles, Mumps, Rubella and Chickenpox (live vaccine)

Intervention Type BIOLOGICAL

Other Intervention Names

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Measles Mumps Rubella and Chickenpox (live vaccine)

Eligibility Criteria

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Inclusion Criteria

* A male or female subject between 11-13 months of age (i.e. from 11 month birthday until the day before the 14 month birthday) at the time of the first vaccination.

Exclusion Criteria

* History of previous measles, mumps, rubella and/or varicella vaccination or disease, or known exposure to any of these diseases within 30 days prior to the start of the trial
* Planned administration of a vaccine not foreseen by the study protocol from 30 days prior to each vaccination until 42-56 days after each vaccination

Minimum Eligible Age

11 Months

Maximum Eligible Age

13 Months

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

Brussels, , Belgium

Site Status

GSK Investigational Site

Leuven, , Belgium

Site Status

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ehingen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Kirchzarten, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ludwigsburg, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Marbach, 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

Tettnang, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bindlach, Bavaria, Germany

Site Status

GSK Investigational Site

Cham, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Olching, Bavaria, Germany

Site Status

GSK Investigational Site

Weilheim, Bavaria, Germany

Site Status

GSK Investigational Site

Werneck, Bavaria, Germany

Site Status

GSK Investigational Site

Eschwege, Hesse, Germany

Site Status

GSK Investigational Site

Fulda, Hesse, Germany

Site Status

GSK Investigational Site

Niedernhausen, Hesse, Germany

Site Status

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Dortmund, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Espelkamp, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Herford, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hille, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Minden, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Viersen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Glücksburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Neumünster, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, Germany

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

Countries

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Belgium Germany Netherlands

Study Documents

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Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103388 are summarised with followup study 104690 on the GSK Clinical Study Register.

View Document