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

NCT ID: NCT00127023

Last Updated: 2016-09-21

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

944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-11-30

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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Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

Conditions

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Mumps Varicella Rubella Measles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

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

21 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

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

Bad Saulgau, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ehingen, Baden-Wurttemberg, Germany

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GSK Investigational Site

Eppelheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Herbolzheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

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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

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Marbach, Baden-Wurttemberg, Germany

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GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

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GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

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GSK Investigational Site

Pfinztal, Baden-Wurttemberg, Germany

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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

Augsburg, Bavaria, Germany

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GSK Investigational Site

Bindlach, Bavaria, Germany

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GSK Investigational Site

Marktheidenfeld, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Nuremberg, Bavaria, Germany

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GSK Investigational Site

Roding, Bavaria, Germany

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GSK Investigational Site

Hamburg, City state of Hamburg, Germany

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GSK Investigational Site

Hamburg, City state of Hamburg, Germany

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GSK Investigational Site

Hamburg, City state of Hamburg, Germany

Site Status

GSK Investigational Site

Fulda, Hesse, Germany

Site Status

GSK Investigational Site

Salzgitter, Lower Saxony, Germany

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GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

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GSK Investigational Site

Bützow, Mecklenburg-Vorpommern, Germany

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GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

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GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

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GSK Investigational Site

Waren, Mecklenburg-Vorpommern, Germany

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GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, Germany

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GSK Investigational Site

Bochum, North Rhine-Westphalia, Germany

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GSK Investigational Site

Detmold, North Rhine-Westphalia, Germany

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GSK Investigational Site

Erkrath, North Rhine-Westphalia, Germany

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GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

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GSK Investigational Site

Hille, North Rhine-Westphalia, Germany

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GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Oberhausen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Bodenheim, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Gerolstein, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

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GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

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GSK Investigational Site

Bischofswerda, Saxony, Germany

Site Status

GSK Investigational Site

Döbeln, Saxony, Germany

Site Status

GSK Investigational Site

Dresden, Saxony, Germany

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GSK Investigational Site

Leipzig, Saxony, Germany

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GSK Investigational Site

Leipzig, Saxony, Germany

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GSK Investigational Site

Stollberg, Saxony, Germany

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GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany

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GSK Investigational Site

Brunsbüttel, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Harrislee, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Mölln, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Neumünster, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Niebüll, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Bad Lobenstein, Thuringia, Germany

Site Status

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, Germany

Site Status

GSK Investigational Site

Weimar, Thuringia, Germany

Site Status

Countries

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Germany

References

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Schuster V, Otto W, Maurer L, Tcherepnine P, Pfletschinger U, Kindler K, Soemantri P, Walther U, Macholdt U, Douha M, Pierson P, Willems P. Immunogenicity and safety assessments after one and two doses of a refrigerator-stable tetravalent measles-mumps-rubella-varicella vaccine in healthy children during the second year of life. Pediatr Infect Dis J. 2008 Aug;27(8):724-30. doi: 10.1097/INF.0b013e318170bb22.

Reference Type BACKGROUND
PMID: 18600190 (View on PubMed)

Schuster V et al. Immunogenicity of a Refrigerator-Stable Tetravalent MMRV Vaccine after One and Two Doses. Presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 3-5 May 2006.

Reference Type BACKGROUND

Schuster V et al. Tolerability of a Refrigerator-Stable Tetravalent MMRV vaccine after One and Two Doses. Presented at the 12th International Congress on Infectious Diseases (ICID), Lisbon, Portugal, 15-18 June 2006.

Reference Type BACKGROUND

Dhillon S, Curran MP. Live attenuated measles, mumps, rubella, and varicella zoster virus vaccine (Priorix-Tetra). Paediatr Drugs. 2008;10(5):337-47. doi: 10.2165/00148581-200810050-00007.

Reference Type BACKGROUND
PMID: 18754700 (View on PubMed)

Study Documents

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Document Type: Statistical Analysis Plan

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Informed Consent Form

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

View Document

Document Type: Clinical Study Report

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

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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104389

Identifier Type: -

Identifier Source: org_study_id

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