Immunogenicity/Safety of Measles-Mumps-Rubella-Varicella Vaccine (MeMuRu-OKA): Using Two Different Administration Routes

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00351923
First received: July 12, 2006
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

This study will compare the immunogenicity and safety of the MeMuRu-OKA vaccine administered subcutaneously or using an alternative administration route.


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
Biological: MeMuRu-OKA (study vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Open, Multicenter, Randomised, Controlled Phase IIIb Study Evaluating the Immunogenicity and Safety of Subcutaneous Versus Alternative Administration Route of Combined MeMuRu-OKA Vaccine to Healthy Children Aged 11 to 21 Months.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroconversion rates after vaccination

Secondary Outcome Measures:
  • Antibody titres; safety: solicited local/ general, unsolicited AEs (42 days), SAEs (whole study)

Estimated Enrollment: 330
Study Start Date: March 2006
Study Completion Date: December 2006
Intervention Details:
    Biological: MeMuRu-OKA (study vaccine)
    Other Name: MeMuRu-OKA (study vaccine)
  Eligibility

Ages Eligible for Study:   11 Months to 22 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children must be healthy and have a birth weight > 2000 g to participate

Exclusion Criteria:

  • confirmed or suspected tuberculosis, immunosuppressive (including HIV) conditions, neurological disorders, history of allergic disease or reaction, major congenital defects, chronical administration of salicylates, and fever (axillary temperature ³ 37.5°C at the time of vaccination) are excluding factors.
  • Children from pregnant mothers who have a negative history of chickenpox are also excluded from the study.
  • Children must have received one dose (but not more) of MMR and of varicella 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 within 30 days before vaccination.
  • Children must not have had measles, mumps, rubella or varicella/zoster, 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: NCT00351923

Locations
Germany
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76189
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
GSK Investigational Site
Eschwege, Hessen, Germany, 37269
GSK Investigational Site
Giessen, Hessen, Germany, 35390
GSK Investigational Site
Bad Kreuznach, Rheinland-Pfalz, Germany, 55543
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55127
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00351923     History of Changes
Other Study ID Numbers: 106670
Study First Received: July 12, 2006
Last Updated: October 9, 2008
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Rubella
Measles
Herpes Zoster
Chickenpox
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Herpesviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 16, 2014