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Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

Primary Purpose

Rubella, Varicella, Mumps

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MMRV
MMR (Priorix®)
Varicella (Varilrix®)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rubella focused on measuring Rubella, Varicella, Measles, Mumps, Germany, Austria

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent from the parents/guardians of the child before participating in the long-term follow-up.
  • Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study.
  • Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study.

Exclusion Criteria:

  • Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.

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

Outcomes

Primary Outcome Measures

Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination

Secondary Outcome Measures

Full Information

First Posted
December 1, 2006
Last Updated
September 14, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00406211
Brief Title
Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine
Official Title
Follow-up to Evaluate the the Immunogenicity & Safety of GSK Biologicals' MMRV Vaccine Given as a Two-dose Schedule in the Second Year of Life, as Compared to Separate Administration of GSK Biologicals' Priorix® & Varilrix®.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Follow-up to evaluate the immunogenicity and safety of three production lots of GSK Biologicals' MMRV vaccine given as a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' measles-mumps-rubella (MMR) vaccine (Priorix®) and varicella vaccine (Varilrix®) in Germany & Austria. Blood samples were collected at three time points during the follow-up period (Year 1, 2 & 3). No new subjects will be enrolled in these follow-up phases of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rubella, Varicella, Mumps, Measles
Keywords
Rubella, Varicella, Measles, Mumps, Germany, Austria

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MMRV
Intervention Type
Biological
Intervention Name(s)
MMR (Priorix®)
Intervention Type
Biological
Intervention Name(s)
Varicella (Varilrix®)
Primary Outcome Measure Information:
Title
Seropositivity rate & antibody titers for MMRV at 1, 2 & 3 year
Title
Occurrence of breakthrough cases & contacts with MMRV disease(s) for 3 years after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Written informed consent from the parents/guardians of the child before participating in the long-term follow-up. Subjects must have received their complete vaccination course according to the group allocation (i.e. subjects must have received either two doses of MMRV combined vaccine, or two doses of Priorix vaccine and one dose of Varilrix vaccine as separate injections in the primary vaccination study. Subjects were aged between 12 to 18 months of age at the time of the first vaccination in the primary study. Exclusion Criteria: Subjects must not have received an additional dose of measles, mumps, rubella or varicella containing vaccines.
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
Klagenfurt
ZIP/Postal Code
A-9020
Country
Austria
Facility Name
GSK Investigational Site
City
Neufeld/Leitha
ZIP/Postal Code
A 2491
Country
Austria
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Villach
ZIP/Postal Code
A-9500
Country
Austria
Facility Name
GSK Investigational Site
City
Bindlach
State/Province
Bayern
ZIP/Postal Code
95463
Country
Germany
Facility Name
GSK Investigational Site
City
Marktredwitz
State/Province
Bayern
ZIP/Postal Code
95615
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
Bad Camberg
State/Province
Hessen
ZIP/Postal Code
65520
Country
Germany
Facility Name
GSK Investigational Site
City
Fulda
State/Province
Hessen
ZIP/Postal Code
36037
Country
Germany
Facility Name
GSK Investigational Site
City
Hochheim
State/Province
Hessen
ZIP/Postal Code
65239
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg/Lahn
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
Facility Name
GSK Investigational Site
City
Nidderau
State/Province
Hessen
ZIP/Postal Code
61130
Country
Germany
Facility Name
GSK Investigational Site
City
Ruesselsheim
State/Province
Hessen
ZIP/Postal Code
65428
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
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44791
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
Guetersloh
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
33332
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
Loehne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32584
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
Bad Kreuznach
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55543
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Sobernheim
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55566
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
Gau-Algesheim
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55435
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55116
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
Schoeneberg - Kuebelberg
State/Province
Rheinland-Pfalz
ZIP/Postal Code
66901
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
Worms
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67547
Country
Germany
Facility Name
GSK Investigational Site
City
Altenholz
State/Province
Schleswig-Holstein
ZIP/Postal Code
24161
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
Husum
State/Province
Schleswig-Holstein
ZIP/Postal Code
25813
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
Hamburg
ZIP/Postal Code
22089
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:
Citation
Habermehl P, Zepp F, Sänger R, Otto W, Helm K, Meister N, Knuf M, Kindler K, Willems P. Assessment of Varicella Breakthrough Cases One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella Vaccine in the Second Year of Life. Abstract presented at the 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
Results Reference
background
PubMed Identifier
18536786
Citation
Knuf M, Faber J, Barth I, Habermehl P. A combination vaccine against measles, mumps, rubella and varicella. Drugs Today (Barc). 2008 Apr;44(4):279-92. doi: 10.1358/dot.2008.44.4.1210755.
Results Reference
background
PubMed Identifier
21935584
Citation
Knuf M, Zepp F, Helm K, Maurer H, Prieler A, Kieninger-Baum D, Douha M, Willems P. Antibody persistence for 3 years following two doses of tetravalent measles-mumps-rubella-varicella vaccine in healthy children. Eur J Pediatr. 2012 Mar;171(3):463-70. doi: 10.1007/s00431-011-1569-4. Epub 2011 Sep 21.
Results Reference
background
Citation
Zepp F et al. Persistence of Functional Antibodies against Mumps Remains High One Year after Administration of Two Doses of a Measles, Mumps, Rubella, Varicella (MMRV) Vaccine in the Second Year of Life. Presented at 24th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID), Basel, Switzerland, 03-05 May 2006.
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
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208136/039
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
208136/039
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
208136/039
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
208136/039
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
208136/039
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
208136/039
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Long-term Follow-up on Immunogenicity & Safety of Measles-Mumps-Rubella-Varicella (MMRV) Combined Vaccine

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