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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01621802
First received: June 14, 2012
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.


Condition Intervention Phase
Rubella
Mumps
Measles
Biological: Priorix®
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Biological: Kinrix®
Biological: Varivax®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given with VV and DTaP-IPV vaccines in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the Inv_MMR vaccine as compared to Com_MMR vaccine when given without VV and DTaP-IPV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to VV in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of DTaP- IPV vaccine in terms of antibody concentration [ Time Frame: 42 days after vaccination (At Day 42) ] [ Designated as safety issue: No ]
  • Occurrence of solicited local symptoms [ Time Frame: Days 0-3 ] [ Designated as safety issue: No ]
  • Occurrence of solicited general symptoms [ Time Frame: Days 0-42 ] [ Designated as safety issue: No ]
  • Occurrence of Adverse events of specific interest [ Time Frame: From Day 0 through the end of study (Day 180) ] [ Designated as safety issue: No ]
  • Occurrence of Unsolicited adverse events [ Time Frame: From Day 0 to Day 42 ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From Day 0 through end of study (Day 180) ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inv _MMR_co
Subjects will receive 1 dose of the study vaccine (Priorix®) co administered with DTaP-IPV and VV vaccines at Day 0
Biological: Priorix®
Single dose administered subcutaneously (SC) with or without licensed co-administered vaccines, DTaP-IPV and varicella
Biological: Kinrix®
Single dose administered SC with varicella vaccine and with either Priorix® or M-M-R®II
Biological: Varivax®
Single dose administered SC with DTaP-IPV vaccine and with either Priorix® or M-M-R®
Active Comparator: Com_MMR_L1_co
Subjects will receive 1 dose of the licensed vaccine (M-M-R®II or M-M-R Vax Pro™) lot 1 co administered with DTaP-IPV and VV vaccines at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Biological: Kinrix®
Single dose administered SC with varicella vaccine and with either Priorix® or M-M-R®II
Biological: Varivax®
Single dose administered SC with DTaP-IPV vaccine and with either Priorix® or M-M-R®
Active Comparator: Com_MMR_L2_co
Subjects will receive 1 dose of the licensed vaccine ((M-M-R®II or M-M-R Vax Pro™) lot 2 co administered with DTaP-IPV and VV vaccines at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Biological: Kinrix®
Single dose administered SC with varicella vaccine and with either Priorix® or M-M-R®II
Biological: Varivax®
Single dose administered SC with DTaP-IPV vaccine and with either Priorix® or M-M-R®
Experimental: Inv_MMR_i
Subjects will receive 1 dose of the study vaccine at Day 0
Biological: Priorix®
Single dose administered subcutaneously (SC) with or without licensed co-administered vaccines, DTaP-IPV and varicella
Active Comparator: Com_MMR_L1_i
Subjects will receive 1 dose of the licensed vaccine lot 1 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Active Comparator: Com_MMR_L2_i
Subjects will receive 1 dose of the licensed vaccine lot 2 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Experimental: Inv _MMR_s
Subjects will receive 1 dose of the study vaccine at Day 0
Biological: Priorix®
Single dose administered subcutaneously (SC) with or without licensed co-administered vaccines, DTaP-IPV and varicella
Active Comparator: Com_MMR_L1_s
Subjects will receive 1 dose of the licensed vaccine lot 1 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines
Active Comparator: Com_MMR_L2_s
Subjects will receive 1 dose of the licensed vaccine lot 2 at Day 0
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine (also known as M-M-R Vax Pro™)
Single dose administered SC with or without DTaP-IPV and varicella vaccines

Detailed Description:

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.

  Eligibility

Ages Eligible for Study:   4 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
  • Male or female subjects 4 to 6 years of age at the time of vaccination.
  • Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
  • Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
  • Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
  • For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:

    • subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
    • subjects received a first dose of VV in the second year of life.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
  • Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of measles, mumps, and/or rubella disease.
  • Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin.
  • Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
  • Active untreated tuberculosis according to the subject's medical history.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:

  • Previous vaccination with a second dose of varicella-containing vaccine.
  • Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
  • History of varicella/zoster disease.
  • Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
  • History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
  • Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
  • Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
  • Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
  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: NCT01621802

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site Recruiting
Birmingham, Alabama, United States, 35205
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Arizona
GSK Investigational Site Recruiting
Tucscon, Arizona, United States, 85704
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Tucson, Arizona, United States, 85741
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Arkansas
GSK Investigational Site Recruiting
Benton, Arkansas, United States, 72019
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Fayetteville, Arkansas, United States, 72703
GSK Investigational Site Completed
Little Rock, Arkansas, United States, 72205
United States, California
GSK Investigational Site Recruiting
Anaheim, California, United States, 92804
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Baldwin Park, California, United States, 91706
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Daly City, California, United States, 94015
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Fresno, California, United States, 93726
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hayward, California, United States, 94545
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Oakland, California, United States, 94611
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Pleasanton, California, United States, 94588
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sacramento, California, United States, 95823
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Sacramento, California, United States, 95815
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Santa Clara, California, United States, 95051
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Walnut Creek, California, United States, 94596
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Colorado
GSK Investigational Site Recruiting
Colorado Springs, Colorado, United States, 80922
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Florida
GSK Investigational Site Recruiting
Altamonte Springs, Florida, United States, 32701
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Georgia
GSK Investigational Site Recruiting
Marietta, Georgia, United States, 30062
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Woodstock, Georgia, United States, 30189
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Idaho
GSK Investigational Site Recruiting
Nampa, Idaho, United States, 83686
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Indiana
GSK Investigational Site Completed
Indianapolis, Indiana, United States, 46256
United States, Kansas
GSK Investigational Site Completed
Augusta, Kansas, United States, 67010
GSK Investigational Site Completed
Newton, Kansas, United States, 67114
United States, Kentucky
GSK Investigational Site Recruiting
Bardstown, Kentucky, United States, 40004
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Louisiana
GSK Investigational Site Terminated
Shreveport, Louisiana, United States, 71103
United States, Maryland
GSK Investigational Site Completed
Columbia, Maryland, United States, 21045
United States, Massachusetts
GSK Investigational Site Recruiting
Fall River, Massachusetts, United States, 02721
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, New York
GSK Investigational Site Recruiting
Bronx, New York, United States, 10467
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, North Carolina
GSK Investigational Site Recruiting
Asheboro, North Carolina, United States, 27203
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Raleigh, North Carolina, United States, 27609
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Ohio
GSK Investigational Site Recruiting
Cincinnati, Ohio, United States, 45245
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Cleveland, Ohio, United States, 44121
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Dayton, Ohio, United States, 45406
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Dayton, Ohio, United States, 45414
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Not yet recruiting
Hilliard, Ohio, United States, 43026
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Oregon
GSK Investigational Site Completed
Gresham, Oregon, United States, 97030
United States, Pennsylvania
GSK Investigational Site Recruiting
Erie, Pennsylvania, United States, 16505
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, South Carolina
GSK Investigational Site Recruiting
Charleston, South Carolina, United States, 29414
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Cheraw, South Carolina, United States, 29520
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, South Dakota
GSK Investigational Site Recruiting
Rapid City, South Dakota, United States, 57701
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Texas
GSK Investigational Site Recruiting
Houston, Texas, United States, 77055
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Tomball, Texas, United States, 77375
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Utah
GSK Investigational Site Recruiting
Provo, Utah, United States, 84604
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
South Jordan, Utah, United States, 84095
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
St. George, Utah, United States, 84790
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Virginia
GSK Investigational Site Completed
Burke, Virginia, United States, 22015
GSK Investigational Site Completed
Charlottesville, Virginia, United States, 22902
United States, West Virginia
GSK Investigational Site Recruiting
Huntington, West Virginia, United States, 25701
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Wisconsin
GSK Investigational Site Recruiting
Monroe, Wisconsin, United States, 53566
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Korea, Republic of
GSK Investigational Site Completed
Ansan, Korea, Republic of, 425-707
GSK Investigational Site Completed
Daegu, Korea, Republic of, 700-712
GSK Investigational Site Completed
Daejeon, Korea, Republic of, 301-723
GSK Investigational Site Completed
Gyeonggi-do, Korea, Republic of, 431-070
GSK Investigational Site Completed
GyeongSangNam-do, Korea, Republic of, 641-560
GSK Investigational Site Completed
Iksan, Korea, Republic of, 570-711
GSK Investigational Site Completed
Jeonju Jeonbuk, Korea, Republic of, 561-712
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 130-702
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Seoul, Korea, Republic of, 158-710
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 139-706
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Seoul, Korea, Republic of, 120-752
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Wonju-si Kangwon-do, Korea, Republic of, 220-701
Puerto Rico
GSK Investigational Site Terminated
San Germán, Puerto Rico, 00683
GSK Investigational Site Terminated
Santurce, Puerto Rico, 00912
Taiwan
GSK Investigational Site Recruiting
New Taipei, Taiwan, 220
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Taichung, Taiwan, 404
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Taipei, Taiwan, 104
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Taipei, Taiwan, 100
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Taoyuan, Taiwan, 333
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01621802     History of Changes
Other Study ID Numbers: 115158, 2011-004638-32
Study First Received: June 14, 2012
Last Updated: November 20, 2014
Health Authority: Korea: Food and Drug Administration
United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:
Measles, mumps and rubella diseases
Immunogenicity
Safety

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

ClinicalTrials.gov processed this record on November 25, 2014