Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
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
1 other identifier
interventional
446
3 countries
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2006
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 17, 2006
CompletedFirst Posted
Study publicly available on registry
July 18, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 7, 2016
October 1, 2016
8 months
July 17, 2006
October 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Varicella seroconversion and MMR titres at 42-56 days after first vaccination
Secondary Outcomes (1)
Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
Interventions
Eligibility Criteria
You may qualify if:
- Children must be healthy to participate
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (39)
GSK Investigational Site
Ancenis, 44150, France
GSK Investigational Site
Boulogne, 92100, France
GSK Investigational Site
Dax, 40100, France
GSK Investigational Site
Draguignan, 83300, France
GSK Investigational Site
Essey-lès-Nancy, 54270, France
GSK Investigational Site
Laon, 02000, France
GSK Investigational Site
Le Havre, 76600, France
GSK Investigational Site
Lingolsheim, 67380, France
GSK Investigational Site
Lyon, 69437, France
GSK Investigational Site
Nice, 06300, France
GSK Investigational Site
Paris, 75019, France
GSK Investigational Site
Villeneuve Les Avignons, 30400, France
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Kirchzarten, Baden-Wurttemberg, 79199, Germany
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
GSK Investigational Site
Schwieberdingen, Baden-Wurttemberg, 71701, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tettnang, Baden-Wurttemberg, 88069, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Werneck, Bavaria, 97440, Germany
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549, Germany
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756, Germany
GSK Investigational Site
Herford, North Rhine-Westphalia, 32049, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944, Germany
GSK Investigational Site
Neumünster, Schleswig-Holstein, 24534, Germany
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Milan, Lombardy, 20122, Italy
GSK Investigational Site
Cagliari, Sardinia, 09127, Italy
GSK Investigational Site
Sassari, Sardinia, 07100, Italy
Related Publications (1)
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.
PMID: 19007835BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2006
First Posted
July 18, 2006
Study Start
March 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.