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
  Purpose

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.


Condition Intervention Phase
Rubella
Varicella
Mumps
Measles
Biological: MeMuRu-OKA (study vac)
Biological: MMR, Varicella vacc (control)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Varicella, MMR titres at 42-56 days after first vaccination

Secondary Outcome Measures:
  • Seropositivity rates. Safety: solicited local/general, unsolicited AEs (42 days), SAEs (whole study)

Estimated Enrollment: 400
Study Start Date: April 2006
Intervention Details:
    Biological: MeMuRu-OKA (study vac) Biological: MMR, Varicella vacc (control)
    Other Names:
    • MMR
    • Varicella vacc (control)
    • MeMuRu-OKA (study vac)
  Eligibility

Ages Eligible for Study:   15 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352898

Locations
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5N 4A3
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V6H 3N1
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Italy
GSK Investigational Site
Enna, Sicilia, Italy, 94015
GSK Investigational Site
Ragusa, Sicilia, Italy, 97100
GSK Investigational Site
San Gregorio di Catania (CT), Sicilia, Italy, 95027
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00352898     History of Changes
Other Study ID Numbers: 105909
Study First Received: July 14, 2006
Last Updated: September 29, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Rubella
Chickenpox
Herpes Zoster
Measles
Mumps
Parotitis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on July 22, 2014