ClinicalTrials.gg
CompletedNCT00353288Updated Oct 7, 2016

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

A Phase 2 interventional study of MeMuRu-OKA (study vacc) and MMR, Varicella vacc (control) in Varicella, Rubella and Measles, sponsored by GlaxoSmithKline. Completed at 39 sites in 3 countries. Open to participants aged 15 Months to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-07.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
446
Allocation
Randomized
Ages
15 Months to 6 Years
Sex
All
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Study 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.

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Conditions studied

  • Varicella
  • Rubella
  • Measles
  • Mumps
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In context

Chickenpox

180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.

This study's enrollment of 446 is close to the median of 475 across 149 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Months to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children must be healthy to participate

Exclusion criteria

Exclusion Criteria:

  • (including ) 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

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Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
446 participants (actual)

Interventions

  • BiologicalMeMuRu-OKA (study vacc)
  • BiologicalMMR, Varicella vacc (control)
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What researchers measure

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)

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Study locations

39 sites
  • 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 les 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-Wuerttemberg 88348, Germany
  • GSK Investigational Site
    Boennigheim, Baden-Wuerttemberg 74357, Germany
  • GSK Investigational Site
    Kehl, Baden-Wuerttemberg 77694, Germany
  • GSK Investigational Site
    Kirchzarten, Baden-Wuerttemberg 79199, Germany
  • GSK Investigational Site
    Schwaebisch-Hall, Baden-Wuerttemberg 74523, Germany
  • GSK Investigational Site
    Schwieberdingen, Baden-Wuerttemberg 71701, Germany
  • GSK Investigational Site
    Stuttgart, Baden-Wuerttemberg 70469, Germany
  • GSK Investigational Site
    Tettnang, Baden-Wuerttemberg 88069, Germany
  • GSK Investigational Site
    Bindlach, Bayern 95463, Germany
  • GSK Investigational Site
    Cham, Bayern 93413, Germany
  • GSK Investigational Site
    Kempten, Bayern 87435, Germany
  • GSK Investigational Site
    Muenchen, Bayern 81241, Germany
  • GSK Investigational Site
    Olching, Bayern 82140, Germany
  • GSK Investigational Site
    Werneck, Bayern 97440, Germany
  • GSK Investigational Site
    Bad Oeynhausen, Nordrhein-Westfalen 32549, Germany
  • GSK Investigational Site
    Detmold, Nordrhein-Westfalen 32756, Germany
  • GSK Investigational Site
    Herford, Nordrhein-Westfalen 32049, Germany
  • GSK Investigational Site
    Krefeld, Nordrhein-Westfalen 47798, Germany
  • GSK Investigational Site
    Loehne, Nordrhein-Westfalen 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
    Neumuenster, Schleswig-Holstein 24534, Germany
  • GSK Investigational Site
    Genova, Liguria 16132, Italy
  • GSK Investigational Site
    Milano, Lombardia 20122, Italy
  • GSK Investigational Site
    Cagliari, Sardegna 09127, Italy
  • GSK Investigational Site
    Sassari, Sardegna 07100, Italy
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References and documents

Publications

  • 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. PubMed 19007835 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00353288
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 18, 2006
Start date
Mar 2006
Primary completion
Nov 2006
Completion
Nov 2006
Last update
Oct 7, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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