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

Primary Purpose

Mumps, Varicella, Rubella

Status
Completed
Phase
Phase 3
Locations
Germany
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 prevention 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
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  • 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
NCT00127023
Brief Title
Immunogenicity and Safety of a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Official Title
Blinded, Randomised, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Combined Measles-mumps-rubella-varicella Candidate Vaccine 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
undefined (undefined)
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 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.
Detailed Description
Separate injections of the licensed Priorix (MMR vaccine) and Varilrix (chickenpox vaccine) serve as control.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
944 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, Rubella and Chickenpox (live vaccine)
Other 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
Bad Saulgau
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88348
Country
Germany
Facility Name
GSK Investigational Site
City
Boennigheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74357
Country
Germany
Facility Name
GSK Investigational Site
City
Bretten
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
75015
Country
Germany
Facility Name
GSK Investigational Site
City
Ehingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89584
Country
Germany
Facility Name
GSK Investigational Site
City
Eppelheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69214
Country
Germany
Facility Name
GSK Investigational Site
City
Ettenheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77955
Country
Germany
Facility Name
GSK Investigational Site
City
Herbolzheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79336
Country
Germany
Facility Name
GSK Investigational Site
City
Karlsruhe
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76185
Country
Germany
Facility Name
GSK Investigational Site
City
Kehl
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
GSK Investigational Site
City
Kirchzarten
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
79199
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigsburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71634
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68161
Country
Germany
Facility Name
GSK Investigational Site
City
Mannheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
68309
Country
Germany
Facility Name
GSK Investigational Site
City
Marbach
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71672
Country
Germany
Facility Name
GSK Investigational Site
City
Oberkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77704
Country
Germany
Facility Name
GSK Investigational Site
City
Oberstenfeld
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71720
Country
Germany
Facility Name
GSK Investigational Site
City
Offenburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77654
Country
Germany
Facility Name
GSK Investigational Site
City
Offenburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77656
Country
Germany
Facility Name
GSK Investigational Site
City
Pfinztal
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76327
Country
Germany
Facility Name
GSK Investigational Site
City
Schwaebisch-Hall
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74523
Country
Germany
Facility Name
GSK Investigational Site
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70469
Country
Germany
Facility Name
GSK Investigational Site
City
Tauberbischofsheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
97941
Country
Germany
Facility Name
GSK Investigational Site
City
Tettnang
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88069
Country
Germany
Facility Name
GSK Investigational Site
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86163
Country
Germany
Facility Name
GSK Investigational Site
City
Bindlach
State/Province
Bayern
ZIP/Postal Code
95463
Country
Germany
Facility Name
GSK Investigational Site
City
Marktheidenfeld
State/Province
Bayern
ZIP/Postal Code
97828
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90473
Country
Germany
Facility Name
GSK Investigational Site
City
Roding
State/Province
Bayern
ZIP/Postal Code
93426
Country
Germany
Facility Name
GSK Investigational Site
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36037
Country
Germany
Facility Name
GSK Investigational Site
City
Buetzow
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18246
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18059
Country
Germany
Facility Name
GSK Investigational Site
City
Rostock
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
18146
Country
Germany
Facility Name
GSK Investigational Site
City
Waren
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17192
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
Erkrath
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40699
Country
Germany
Facility Name
GSK Investigational Site
City
Heiligenhaus
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42579
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
Kleve-Materborn
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47533
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
Oberhausen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46145
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
Bad Kreuznach
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55543
Country
Germany
Facility Name
GSK Investigational Site
City
Bodenheim
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55294
Country
Germany
Facility Name
GSK Investigational Site
City
Frankenthal
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67227
Country
Germany
Facility Name
GSK Investigational Site
City
Gerolstein
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54568
Country
Germany
Facility Name
GSK Investigational Site
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67059
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54294
Country
Germany
Facility Name
GSK Investigational Site
City
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany
Facility Name
GSK Investigational Site
City
Bischofswerda
State/Province
Sachsen
ZIP/Postal Code
01877
Country
Germany
Facility Name
GSK Investigational Site
City
Doebeln
State/Province
Sachsen
ZIP/Postal Code
04720
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01169
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04178
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04317
Country
Germany
Facility Name
GSK Investigational Site
City
Stollberg
State/Province
Sachsen
ZIP/Postal Code
09366
Country
Germany
Facility Name
GSK Investigational Site
City
Bredstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
25821
Country
Germany
Facility Name
GSK Investigational Site
City
Brunsbuettel
State/Province
Schleswig-Holstein
ZIP/Postal Code
25541
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24937
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24943
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24944
Country
Germany
Facility Name
GSK Investigational Site
City
Harrislee
State/Province
Schleswig-Holstein
ZIP/Postal Code
24955
Country
Germany
Facility Name
GSK Investigational Site
City
Husum
State/Province
Schleswig-Holstein
ZIP/Postal Code
25813
Country
Germany
Facility Name
GSK Investigational Site
City
Moelln
State/Province
Schleswig-Holstein
ZIP/Postal Code
23879
Country
Germany
Facility Name
GSK Investigational Site
City
Neumuenster
State/Province
Schleswig-Holstein
ZIP/Postal Code
24534
Country
Germany
Facility Name
GSK Investigational Site
City
Niebuell
State/Province
Schleswig-Holstein
ZIP/Postal Code
25899
Country
Germany
Facility Name
GSK Investigational Site
City
Lobenstein
State/Province
Thueringen
ZIP/Postal Code
07356
Country
Germany
Facility Name
GSK Investigational Site
City
Neuhaus am Rennweg
State/Province
Thueringen
ZIP/Postal Code
98724
Country
Germany
Facility Name
GSK Investigational Site
City
Weimar
State/Province
Thueringen
ZIP/Postal Code
99425
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10315
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10999
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
12679
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14197
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22089
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22307
Country
Germany

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.
Citations:
PubMed Identifier
18600190
Citation
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. Erratum In: Pediatr Infect Dis J. 2013 Apr;32(4):e163.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18754700
Citation
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.
Results Reference
background
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
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104389
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104389
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
104389
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
104389
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
104389
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
104389
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 a Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases

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