Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01681992
First received: September 6, 2012
Last updated: October 2, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).


Condition Intervention Phase
Measles
Mumps
Rubella
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Biological: Merck & Co., Inc.'s M-M-R®II, combined measles-mumps-rubella virus vaccine live.
Biological: Varivax® (Merck & Co., Inc.)
Biological: Havrix®
Biological: Prevnar 13® (Pfizer Inc.)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety Study of GSK Biologicals' Priorix® Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s MMR Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity of the MMR vaccines [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]
    Seroresponses for MMR are defined as a post-vacc., anti-virus Ab conc. in children who were seronegative pre-vacc. as follows: For measles virus, a post-vacc. anti-measles virus Ab conc. of ≥200 mIU/mL (ELISA) in children <150 mIU/mL pre-vacc.; For mumps virus, a post-vacc. anti-mumps virus Ab conc. ≥10 EU/mL (ELISA) in children <5 EU/mL pre-vacc.; For mumps virus as measured by PRNT, a post-vacc. anti-mumps virus Ab conc. ≥4 ED50 (PRNT) in children <2.5 ED50 before Dose 1; For rubella virus, a post-vacc. anti-rubella virus Ab conc. ≥10 IU/mL (ELISA) in children <4 IU/mL pre-vacc.


Secondary Outcome Measures:
  • Immunogenicity of the MMR vaccines post-dose 2 (US post-dose 2 sub-cohort) in terms of antibody concentration. [ Time Frame: At Day 84 ] [ 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 Unsolicited adverse events. [ 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 222) ] [ Designated as safety issue: No ]
  • Serious adverse events (SAEs). [ Time Frame: From Day 0 through the end of study (Day 222) ] [ Designated as safety issue: No ]

Estimated Enrollment: 4500
Study Start Date: October 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inv_MMR_ Min Group
Subjects will receive 1 dose of Inv_MMR vaccine (i.e. Inv_MMR_Min) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13. Approximately 6 weeks later (Visit 2), subjects will be administered a separate lot of the Inv_MMR vaccine (Inv_MMR_Release) for the second dose.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) of either Inv_MMR_Min or Inv_MMR_Med depending on group assigned followed by a second SC injection of Inv_MMR_Release about 6 weeks later.
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Experimental: Inv_MMR_Med Group
Subjects will receive 1 dose of Inv_MMR vaccine (i.e. Inv_MMR_Med) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13. Approximately 6 weeks later (Visit 2), subjects will be administered a separate lot of the Inv_MMR vaccine (Inv_MMR_Release) for the second dose.
Biological: GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762).
Single dose administered subcutaneously (SC) of either Inv_MMR_Min or Inv_MMR_Med depending on group assigned followed by a second SC injection of Inv_MMR_Release about 6 weeks later.
Other Name: Priorix®
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Active Comparator: Com_MMR_L1 Group
Subjects will receive 1 dose of Com_MMR lot 1 vaccine (i.e. Com_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13. Approximately 6 weeks later (Visit 2), subjects will be administered Com_MMR_L1 or Com_MMR_L2 for the second dose.
Biological: Merck & Co., Inc.'s M-M-R®II, combined measles-mumps-rubella virus vaccine live.
Single dose administered by SC injection of either Com_MMR_L1 or Com_MMR_L2 depending on group assigned followed by a second dose SC injection of either Com_MMR_L1 or Com_MMR_L2 about 6 weeks later.
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Active Comparator: Com_MMR_L2 Group
Subjects will receive 1 dose of Com_MMR lot 2 vaccine (i.e. Com_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects will also be given Prevnar 13. Approximately 6 weeks later (Visit 2), subjects will be administered Com_MMR_L1 or Com_MMR_L2 for the second dose.
Biological: Merck & Co., Inc.'s M-M-R®II, combined measles-mumps-rubella virus vaccine live.
Single dose administered by SC injection of either Com_MMR_L1 or Com_MMR_L2 depending on group assigned followed by a second dose SC injection of either Com_MMR_L1 or Com_MMR_L2 about 6 weeks later.
Biological: Varivax® (Merck & Co., Inc.)
Single dose SC injection administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Havrix®
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).
Biological: Prevnar 13® (Pfizer Inc.)
Single dose Intramuscular injection (IM) administered at Visit 1 (Day 0) in subjects enrolled in US with either one of two Inv_MMR vaccine lots (Inv_MMR_Min or Inv_MMR_Med) or one of two active control Com_MMR vaccine lots (Com_MMR_L1 and Com_MMR_L2).

Detailed Description:

This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. This study will evaluate the immunogenicity and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR vaccine, throughout this document) in contrast to the US standard of care comparator vaccine (M M R®II, Merck and Co., Inc., referred to as Com_MMR throughout this document) in children during their second year of life. The first dose of this two-dose study is designed to establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of these Inv_MMR groups will have a potency within the release range of the marketed vaccine. The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely administered to children of this age in the US.

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female child between 12 and 15 months of age at the time of vaccination.
  • The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, can, and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the child.
  • Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.

For US children only:

• Child that previously received a 3-dose series of Prevnar 13 at least 60 days prior to study entry.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the day of study vaccination or planned use during the entire study period.
  • Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product. Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.

    • Inhaled and topical steroids are allowed.
  • Planned administration / administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:

    • Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
    • Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), and anytime thereafter.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2, or at Visit 3 for the US post-dose 2 sub-cohort.
  • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the first study vaccination.
  • Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex 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 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 based on medical history.
  • Any other condition which, in the opinion of the Investigator, prevents the child from participating in the study.

For US children only:

• A child that previously received a fourth dose of any pneumococcal conjugate vaccine.

  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: NCT01681992

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
Phoenix, Arizona, United States, 85004
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
Phoenix, Arizona, United States, 85032
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
Jonesboro, Arkansas, United States, 72401
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
Little Rock, Arkansas, United States, 72205
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, California
GSK Investigational Site Not yet recruiting
Anaheim, California, United States, 92805
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
Long Beach, California, United States, 90813
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
West Covina, California, United States, 91790
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   
GSK Investigational Site Recruiting
Miami, Florida, United States, 33184
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
Miami Lakes, Florida, United States, 33014
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
Naples, Florida, United States, 34102
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
Tampa, Florida, United States, 33606
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 Recruiting
Muncie, Indiana, United States, 47304-5547
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
New Albany, Indiana, United States, 47150
United States, Iowa
GSK Investigational Site Completed
West Des Moines, Iowa, United States, 50265
United States, Kansas
GSK Investigational Site Recruiting
Wichita, Kansas, United States, 67205
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, Kentucky
GSK Investigational Site Recruiting
Louisville, Kentucky, United States, 40207
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 Terminated
Nicholasville, Kentucky, United States, 40356
United States, Maryland
GSK Investigational Site Recruiting
Annapolis, Maryland, United States, 21401
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
Baltimore, Maryland, United States, 21201
GSK Investigational Site Recruiting
Frederick, Maryland, United States, 21702
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, Missouri
GSK Investigational Site Recruiting
Kansas City, Missouri, United States, 64108
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, Nebraska
GSK Investigational Site Terminated
Bellevue, Nebraska, United States, 68123
GSK Investigational Site Terminated
Fremont, Nebraska, United States, 68025
GSK Investigational Site Recruiting
Lincoln, Nebraska, United States, 68504
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
Lincoln, Nebraska, United States, 68506
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
Omaha, Nebraska, United States, 68131
United States, North Carolina
GSK Investigational Site Recruiting
Clyde, North Carolina, United States, 28721
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 Terminated
Holly Springs, North Carolina, United States, 27540
United States, Ohio
GSK Investigational Site Recruiting
Cleveland, Ohio, United States, 44106
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
Youngstown, Ohio, United States, 44505
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
Youngstown, Ohio, United States, 44514
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 Recruiting
Gresham, Oregon, United States, 97030
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, Pennsylvania
GSK Investigational Site Not yet recruiting
Indiana, Pennsylvania, United States, 15701
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
Johnstown, Pennsylvania, United States, 15904
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 Completed
Charleston, South Carolina, United States, 29414
GSK Investigational Site Recruiting
Charleston, South Carolina, United States, 29406
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, 77074
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
Waco, Texas, United States, 76710
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
Layton, Utah, United States, 84041
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
Springville, Utah, United States, 84663
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 Recruiting
Midlothian, Virginia, United States, 23113
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
Richmond, Virginia, United States, 23223
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 Terminated
Richmond, Virginia, United States, 23294
United States, Washington
GSK Investigational Site Recruiting
Ellensburg, Washington, United States, 98926
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   
Czech Republic
GSK Investigational Site Recruiting
Benesov, Czech Republic, 256 01
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
Chlumec nad Cidlinou, Czech Republic, 50351
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
Decin, Czech Republic, 405 01
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
Jindrichuv Hradec, Czech Republic, 37701
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
Kladno, Czech Republic, 272 01
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
Liberec, Czech Republic, 46015
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
Lipnik nad Becvou, Czech Republic, 75131
GSK Investigational Site Recruiting
Nachod, Czech Republic, 547 01
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
Odolena voda, Czech Republic, 25070
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
Ostrava - Poruba, Czech Republic, 70800
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
Pardubice, Czech Republic, 532 03
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 Terminated
Plzen, Czech Republic, 305 99
GSK Investigational Site Recruiting
Praha 6, Czech Republic, 1600
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   
Finland
GSK Investigational Site Recruiting
Helsinki, Finland, 00100
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
Jarvenpaa, Finland, 04400
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
Oulu, Finland, 90220
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
Tampere, Finland, 33100
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
Turku, Finland, 20520
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
Vantaa, Finland, 01300
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   
Malaysia
GSK Investigational Site Recruiting
Kuala Terengganu, Malaysia, 20400
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
Kuching, Malaysia, 93586
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
Sibu, Malaysia, 96000
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   
Puerto Rico
GSK Investigational Site Terminated
Barceloneta, Puerto Rico, 00617
GSK Investigational Site Terminated
Cidra, Puerto Rico, 00739
GSK Investigational Site Recruiting
Guayama, Puerto Rico, 00784
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
Ponce, Puerto Rico, 00716
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
San Juan, Puerto Rico, 00936-5067
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 Terminated
Santurce, Puerto Rico, 00912
Spain
GSK Investigational Site Recruiting
Antequera/Málaga, Spain, 29200
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
Barcelona, Spain, 08042
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
Centelles (Barcelona), Spain, 08540
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
L'Eliana, Valencia, Spain, 46183
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
Manlleu, Spain, 08560
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
Quart de Poblet, Valencia, Spain, 46930
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
Santiago de Compostela, Spain, 15706
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
Sevilla, Spain, 41014
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
Valencia, Spain, 46200
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
Valencia, Spain, 46024
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
Valencia, Spain, 46020
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
Vic, Spain, 08500
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   
Thailand
GSK Investigational Site Completed
Bangkok, Thailand, 10700
GSK Investigational Site Completed
Bangkok, Thailand, 10330
GSK Investigational Site Completed
Bangkok, Thailand, 10400
GSK Investigational Site Recruiting
Chiang mai, Thailand, 50200
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
Patumtani, Thailand, 12121
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01681992     History of Changes
Other Study ID Numbers: 115649, 2011-004905-26
Study First Received: September 6, 2012
Last Updated: October 2, 2014
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
Finland: Finnish Medicines Agency
United States: Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau
Thailand: Ministry of Public Health
Czech Republic: Statni ustav pro kontrolu leciv

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

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 October 20, 2014