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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00352898
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : October 7, 2016
Information provided by (Responsible Party):

July 14, 2006
July 17, 2006
October 7, 2016
April 2006
Not Provided
Varicella, MMR titres at 42-56 days after first vaccination
Same as current
Complete list of historical versions of study NCT00352898 on Archive Site
Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)
Same as current
Not Provided
Not Provided
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Comparative Study Evaluating the Immunogenicity & Safety of MeMuRu-OKA Vaccine & Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Both Measles-mumps-rubella & Varicella Vaccines
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Mumps
  • Rubella
  • Measles
  • Varicella
  • Biological: MeMuRu-OKA (study vac)
  • Biological: MMR, Varicella vacc (control)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
November 2006
Not Provided

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 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.
Sexes Eligible for Study: All
15 Months to 6 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP