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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00352898
First received: July 14, 2006
Last updated: September 29, 2011
Last verified: September 2011

July 14, 2006
September 29, 2011
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 ClinicalTrials.gov 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-adm. 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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Rubella
  • Varicella
  • Mumps
  • Measles
  • Biological: MeMuRu-OKA (study vac)
  • Biological: MMR, Varicella vacc (control)
    Other Names:
    • MMR
    • Varicella vacc (control)
    • MeMuRu-OKA (study vac)
Not Provided
Halperin SA, Ferrera G, Scheifele D, Predy G, Stella G, Cuccia M, Douha M, Willems P. Safety and immunogenicity of a measles-mumps-rubella-varicella vaccine given as a second dose in children up to six years of age. Vaccine. 2009 May 5;27(20):2701-6. Epub 2009 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
Not Provided
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.
Both
15 Months to 6 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   Italy
 
NCT00352898
105909
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

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