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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00353288
First received: July 17, 2006
Last updated: October 6, 2016
Last verified: October 2016
  Purpose
As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in most industrialised countries and varicella vaccination is now being introduced in many countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine was developed for administration convenience and improved compliance to vaccination. To account for situations where children have received a first dose of MMR vaccine without varicella, this study will evaluate the effect of the combined measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A second dose of the monovalent varicella vaccine will be given to all children participating to this trial since there is a current debate on the need of a second dose to induce a full protection against varicella.

Condition Intervention Phase
Varicella
Rubella
Measles
Mumps
Biological: MeMuRu-OKA (study vacc)
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 and Safety of MeMuRu-OKA Vaccine and Measles-mumps-rubella Vaccine (Priorix™) Co-administered With Varicella Vaccine (Varilrix™) in Children Primed With Measles-mumps-rubella Vaccine

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

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

Enrollment: 446
Study Start Date: March 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   15 Months to 6 Years   (Child)
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 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.
  • Children must not have been vaccinated against varicella.
  • 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: NCT00353288

Locations
France
GSK Investigational Site
Ancenis, France, 44150
GSK Investigational Site
Boulogne, France, 92100
GSK Investigational Site
Dax, France, 40100
GSK Investigational Site
Draguignan, France, 83300
GSK Investigational Site
Essey les Nancy, France, 54270
GSK Investigational Site
Laon, France, 02000
GSK Investigational Site
Le Havre, France, 76600
GSK Investigational Site
Lingolsheim, France, 67380
GSK Investigational Site
Lyon, France, 69437
GSK Investigational Site
Nice, France, 06300
GSK Investigational Site
Paris, France, 75019
GSK Investigational Site
Villeneuve les Avignons, France, 30400
Germany
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
GSK Investigational Site
Boennigheim, Baden-Wuerttemberg, Germany, 74357
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site
Kirchzarten, Baden-Wuerttemberg, Germany, 79199
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
GSK Investigational Site
Schwieberdingen, Baden-Wuerttemberg, Germany, 71701
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Tettnang, Baden-Wuerttemberg, Germany, 88069
GSK Investigational Site
Bindlach, Bayern, Germany, 95463
GSK Investigational Site
Cham, Bayern, Germany, 93413
GSK Investigational Site
Kempten, Bayern, Germany, 87435
GSK Investigational Site
Muenchen, Bayern, Germany, 81241
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Werneck, Bayern, Germany, 97440
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Herford, Nordrhein-Westfalen, Germany, 32049
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Italy
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Milano, Lombardia, Italy, 20122
GSK Investigational Site
Cagliari, Sardegna, Italy, 09127
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 105908
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 105908
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 105908
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 105908
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 105908
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 105908
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00353288     History of Changes
Other Study ID Numbers: 105908 
Study First Received: July 17, 2006
Last Updated: October 6, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Rubella
Measles
Chickenpox
Herpes Zoster
Mumps
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 05, 2016