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

Primary Purpose

Mumps, Rubella, Measles

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Chickenpox (live vaccine)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mumps focused on measuring Prophylaxis measles, mumps, rubella and chickenpox

Eligibility Criteria

11 Months - 21 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Antibody levels after vaccination.

Secondary Outcome Measures

Safety of the study vaccines.

Full Information

First Posted
August 4, 2005
Last Updated
September 20, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00126997
Brief Title
Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Official Title
Blinded, Randomised Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-mumps-rubella-varicella Candidate Vaccine When Given to Healthy Children in Their Second Year of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mumps, Rubella, Measles, Varicella
Keywords
Prophylaxis measles, mumps, rubella and chickenpox

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1439 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, Rubella and Chickenpox (live vaccine)
Primary Outcome Measure Information:
Title
Antibody levels after vaccination.
Secondary Outcome Measure Information:
Title
Safety of the study vaccines.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
21 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Espoo
ZIP/Postal Code
02100
Country
Finland
Facility Name
GSK Investigational Site
City
Lahti
ZIP/Postal Code
15140
Country
Finland
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Pori
ZIP/Postal Code
28120
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
GSK Investigational Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
GSK Investigational Site
City
Vantaa
ZIP/Postal Code
01300
Country
Finland
Facility Name
GSK Investigational Site
City
Bayreuth
State/Province
Bayern
ZIP/Postal Code
95444
Country
Germany
Facility Name
GSK Investigational Site
City
Bindlach
State/Province
Bayern
ZIP/Postal Code
95463
Country
Germany
Facility Name
GSK Investigational Site
City
Bobingen
State/Province
Bayern
ZIP/Postal Code
86399
Country
Germany
Facility Name
GSK Investigational Site
City
Cham
State/Province
Bayern
ZIP/Postal Code
93413
Country
Germany
Facility Name
GSK Investigational Site
City
Kempten
State/Province
Bayern
ZIP/Postal Code
87435
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81735
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90473
Country
Germany
Facility Name
GSK Investigational Site
City
Olching
State/Province
Bayern
ZIP/Postal Code
82140
Country
Germany
Facility Name
GSK Investigational Site
City
Tegernsee
State/Province
Bayern
ZIP/Postal Code
83684
Country
Germany
Facility Name
GSK Investigational Site
City
Tutzing
State/Province
Bayern
ZIP/Postal Code
82327
Country
Germany
Facility Name
GSK Investigational Site
City
Veitshoechheim
State/Province
Bayern
ZIP/Postal Code
97209
Country
Germany
Facility Name
GSK Investigational Site
City
Eschwege
State/Province
Hessen
ZIP/Postal Code
37269
Country
Germany
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60389
Country
Germany
Facility Name
GSK Investigational Site
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36037
Country
Germany
Facility Name
GSK Investigational Site
City
Nidderau
State/Province
Hessen
ZIP/Postal Code
61130
Country
Germany
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65205
Country
Germany
Facility Name
GSK Investigational Site
City
Salzgitter
State/Province
Niedersachsen
ZIP/Postal Code
38226
Country
Germany
Facility Name
GSK Investigational Site
City
Wolfenbuettel
State/Province
Niedersachsen
ZIP/Postal Code
38302
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Oeynhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32549
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44866
Country
Germany
Facility Name
GSK Investigational Site
City
Detmold
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32756
Country
Germany
Facility Name
GSK Investigational Site
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44329
Country
Germany
Facility Name
GSK Investigational Site
City
Espelkamp
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32339
Country
Germany
Facility Name
GSK Investigational Site
City
Goch
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47574
Country
Germany
Facility Name
GSK Investigational Site
City
Guetersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
Country
Germany
Facility Name
GSK Investigational Site
City
Hille
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32479
Country
Germany
Facility Name
GSK Investigational Site
City
Kirchlengern
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32278
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47798
Country
Germany
Facility Name
GSK Investigational Site
City
Loehne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32584
Country
Germany
Facility Name
GSK Investigational Site
City
Minden
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32427
Country
Germany
Facility Name
GSK Investigational Site
City
Moenchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41061
Country
Germany
Facility Name
GSK Investigational Site
City
Moenchengladbach
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41236
Country
Germany
Facility Name
GSK Investigational Site
City
Muenster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48159
Country
Germany
Facility Name
GSK Investigational Site
City
Wesseling
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50389
Country
Germany
Facility Name
GSK Investigational Site
City
Willich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47877
Country
Germany
Facility Name
GSK Investigational Site
City
Arta
ZIP/Postal Code
471 00
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
GSK Investigational Site
City
Komotini
ZIP/Postal Code
69100
Country
Greece
Facility Name
GSK Investigational Site
City
Rhodes
ZIP/Postal Code
851 00
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-021
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-709
Country
Poland
Facility Name
GSK Investigational Site
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
GSK Investigational Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104020
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104020
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104020
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104020
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104020
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104020
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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