ClinicalTrials.gg
CompletedNCT00352898Updated 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 vac) and MMR, Varicella vacc (control) in Mumps, Rubella and Measles, sponsored by GlaxoSmithKline. Completed at 6 sites in 2 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
400
Allocation
Randomized
Ages
15 Months to 6 Years
Sex
All
01

Study summary

Since measles-mumps-rubella (MMR) and varicella vaccinations are established as routine childhood practice and often co-administered during the second year of life, a combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine is fully justified. Such a combined vaccine was developed and extensively studied in susceptible children. In countries where varicella mass-vaccination is already implemented, a transition period is necessary as children who started with separate first-dose vaccinations of MMR and varicella will receive a single shot of the combined vaccine as the second dose. To account for those situations, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of separate MMR and varicella vaccines as a second dose.

02

Conditions studied

  • Mumps
  • Rubella
  • Measles
  • Varicella
03

In context

Mumps

83 studies on the registry are indexed under Mumps; 8 are open to participants now.

This study's enrollment of 400 is below the median of 897 across 70 interventional studies indexed under Mumps.

Browse Mumps 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.

04

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 and of varicella vaccine 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. 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.

05

Study design

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

Interventions

  • BiologicalMeMuRu-OKA (study vac)
  • BiologicalMMR, Varicella vacc (control)
06

What researchers measure

Primary outcomes

  1. Varicella, MMR titres at 42-56 days after first vaccination

Secondary outcomes

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

07

Study locations

6 sites
  • GSK Investigational Site
    Edmonton, Alberta T5N 4A3, Canada
  • GSK Investigational Site
    Vancouver, British Columbia V6H 3N1, Canada
  • GSK Investigational Site
    Halifax, Nova Scotia B3K 6R8, Canada
  • GSK Investigational Site
    Enna, Sicilia 94015, Italy
  • GSK Investigational Site
    Ragusa, Sicilia 97100, Italy
  • GSK Investigational Site
    San Gregorio di Catania (CT), Sicilia 95027, Italy
08

References and documents

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.

09

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 ↗
10

Registry details

Key details

Study ID
NCT00352898
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 17, 2006
Start date
Apr 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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