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

NCT ID: NCT00126997

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

PHASE4

Total Enrollment

1439 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 assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their second year of life.

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Detailed Description

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Conditions

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Mumps Rubella Measles Varicella

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Measles, Mumps, Rubella and Chickenpox (live vaccine)

Intervention Type BIOLOGICAL

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

Espoo, , Finland

Site Status

GSK Investigational Site

Lahti, , Finland

Site Status

GSK Investigational Site

Oulu, , Finland

Site Status

GSK Investigational Site

Pori, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

Site Status

GSK Investigational Site

Bayreuth, Bavaria, Germany

Site Status

GSK Investigational Site

Bindlach, Bavaria, Germany

Site Status

GSK Investigational Site

Bobingen, Bavaria, Germany

Site Status

GSK Investigational Site

Cham, Bavaria, Germany

Site Status

GSK Investigational Site

Kempten (Allgäu), Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Nördlingen, Bavaria, Germany

Site Status

GSK Investigational Site

Nuremberg, Bavaria, Germany

Site Status

GSK Investigational Site

Olching, Bavaria, Germany

Site Status

GSK Investigational Site

Tegernsee, Bavaria, Germany

Site Status

GSK Investigational Site

Tutzing, Bavaria, Germany

Site Status

GSK Investigational Site

Veitshöchheim, Bavaria, Germany

Site Status

GSK Investigational Site

Eschwege, Hesse, Germany

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Fulda, Hesse, Germany

Site Status

GSK Investigational Site

Nidderau, Hesse, Germany

Site Status

GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Salzgitter, Lower Saxony, Germany

Site Status

GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

Site Status

GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, 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

Goch, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Gütersloh, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Hille, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Kirchlengern, 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

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Wesseling, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Arta, , Greece

Site Status

GSK Investigational Site

Athens, , Greece

Site Status

GSK Investigational Site

Komotini, , Greece

Site Status

GSK Investigational Site

Rhodes, , Greece

Site Status

GSK Investigational Site

Thessaloniki, , Greece

Site Status

GSK Investigational Site

Bydgoszcz, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Poznan, , Poland

Site Status

GSK Investigational Site

Siemianowice Śląskie, , Poland

Site Status

GSK Investigational Site

Trzebnica, , Poland

Site Status

Countries

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Finland Germany Greece Poland

Study Documents

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Document Type: Dataset Specification

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: Study Protocol

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: Informed Consent Form

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

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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104020

Identifier Type: -

Identifier Source: org_study_id

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