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Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

Primary Purpose

Varicella, Rubella, Measles

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MeMuRu-OKA (study vacc)
MMR, Varicella vacc (control)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

15 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children must be healthy to participate Exclusion Criteria: Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination. Children must not have been vaccinated against varicella. They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start. New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.

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

Outcomes

Primary Outcome Measures

Varicella seroconversion and MMR titres at 42-56 days after first vaccination

Secondary Outcome Measures

Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

Full Information

First Posted
July 17, 2006
Last Updated
October 6, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00353288
Brief Title
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Official Title
Comparative Study Evaluating the Immunogenicity and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
446 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MeMuRu-OKA (study vacc)
Intervention Type
Biological
Intervention Name(s)
MMR, Varicella vacc (control)
Primary Outcome Measure Information:
Title
Varicella seroconversion and MMR titres at 42-56 days after first vaccination
Secondary Outcome Measure Information:
Title
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children must be healthy to participate Exclusion Criteria: Immunosuppressive (including HIV) conditions, allergic diseases, neurological disorders, known anaphylactic reaction to MMR vaccine, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors. Children must have received one dose (but not more) of MMR at least 6 weeks before entering the study. They must not receive or have received other non-registered drug or vaccine within 30 days prior to study start, or immunosuppressants for more than 14 days. Immunoglobulins or any blood products are prohibited during the 6 months before and during the study, as well as vaccine other than that foreseen by the protocol, 30 days before until 56 days after vaccination. Children must not have been vaccinated against varicella. They must not have had measles, mumps, rubella or varicella, or have been exposed to those diseases within 30 days prior to study start. New-born infants (< 5 weeks of age), pregnant women without previous exposure to chickenpox, and immunodeficient persons cannot live in the same household as the vaccinated child.
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
Ancenis
ZIP/Postal Code
44150
Country
France
Facility Name
GSK Investigational Site
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
GSK Investigational Site
City
Dax
ZIP/Postal Code
40100
Country
France
Facility Name
GSK Investigational Site
City
Draguignan
ZIP/Postal Code
83300
Country
France
Facility Name
GSK Investigational Site
City
Essey les Nancy
ZIP/Postal Code
54270
Country
France
Facility Name
GSK Investigational Site
City
Laon
ZIP/Postal Code
02000
Country
France
Facility Name
GSK Investigational Site
City
Le Havre
ZIP/Postal Code
76600
Country
France
Facility Name
GSK Investigational Site
City
Lingolsheim
ZIP/Postal Code
67380
Country
France
Facility Name
GSK Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
GSK Investigational Site
City
Nice
ZIP/Postal Code
06300
Country
France
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
GSK Investigational Site
City
Villeneuve les Avignons
ZIP/Postal Code
30400
Country
France
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
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
Schwaebisch-Hall
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
74523
Country
Germany
Facility Name
GSK Investigational Site
City
Schwieberdingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
71701
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
Tettnang
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
88069
Country
Germany
Facility Name
GSK Investigational Site
City
Bindlach
State/Province
Bayern
ZIP/Postal Code
95463
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
Olching
State/Province
Bayern
ZIP/Postal Code
82140
Country
Germany
Facility Name
GSK Investigational Site
City
Werneck
State/Province
Bayern
ZIP/Postal Code
97440
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
Detmold
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32756
Country
Germany
Facility Name
GSK Investigational Site
City
Herford
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
32049
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
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
Neumuenster
State/Province
Schleswig-Holstein
ZIP/Postal Code
24534
Country
Germany
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
GSK Investigational Site
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09127
Country
Italy
Facility Name
GSK Investigational Site
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy

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
19007835
Citation
Gillet Y, Steri GC, Behre U, Arsene JP, Lanse X, Helm K, Esposito S, Meister N, Desole MG, Douha M, Willems P. Immunogenicity and safety of measles-mumps-rubella-varicella (MMRV) vaccine followed by one dose of varicella vaccine in children aged 15 months-2 years or 2-6 years primed with measles-mumps-rubella (MMR) vaccine. Vaccine. 2009 Jan 14;27(3):446-53. doi: 10.1016/j.vaccine.2008.10.064. Epub 2008 Nov 11.
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
105908
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
105908
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
105908
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
105908
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
105908
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
105908
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™

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