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).
Minimum age: 12 Months.
Maximum age: 15 Months.
Gender(s): Both.
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 with last dose 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.
GSK Investigational Site, Benesov 256 01, Czech Republic
GSK Investigational Site, Chlumec nad Cidlinou 50351, Czech Republic
GSK Investigational Site, Decin 405 01, Czech Republic
GSK Investigational Site, Jindrichuv Hradec 37701, Czech Republic
GSK Investigational Site, Kladno 272 01, Czech Republic
GSK Investigational Site, Liberec 46015, Czech Republic
GSK Investigational Site, Lipnik nad Becvou 75131, Czech Republic
GSK Investigational Site, Nachod 547 01, Czech Republic
GSK Investigational Site, Odolena voda 25070, Czech Republic
GSK Investigational Site, Ostrava - Poruba 70800, Czech Republic
GSK Investigational Site, Pardubice 532 03, Czech Republic
GSK Investigational Site, Plzen 305 99, Czech Republic
GSK Investigational Site, Praha 6 1600, Czech Republic
GSK Investigational Site, Helsinki 00100, Finland
GSK Investigational Site, Helsinki 00930, Finland
GSK Investigational Site, Jarvenpaa 04400, Finland
GSK Investigational Site, Oulu 90220, Finland
GSK Investigational Site, Tampere 33100, Finland
GSK Investigational Site, Turku 20520, Finland
GSK Investigational Site, Kuala Terengganu 20400, Malaysia
GSK Investigational Site, Kuching 93586, Malaysia
GSK Investigational Site, Sibu 96000, Malaysia
GSK Investigational Site, Barceloneta 00617, Puerto Rico
GSK Investigational Site, Cidra 00739, Puerto Rico
GSK Investigational Site, Guayama 00784, Puerto Rico
GSK Investigational Site, Ponce 00716, Puerto Rico
GSK Investigational Site, San Juan 00936-5067, Puerto Rico
GSK Investigational Site, Santurce 00912, Puerto Rico
GSK Investigational Site, Antequera/Málaga 29200, Spain
GSK Investigational Site, Barcelona 08042, Spain
GSK Investigational Site, Centelles (Barcelona) 08540, Spain
GSK Investigational Site, L'Eliana, Valencia 46183, Spain
GSK Investigational Site, Manlleu 08560, Spain
GSK Investigational Site, Quart de Poblet, Valencia 46930, Spain
GSK Investigational Site, Santiago de Compostela 15706, Spain
GSK Investigational Site, Sevilla 41014, Spain
GSK Investigational Site, Valencia 46020, Spain
GSK Investigational Site, Valencia 46024, Spain
GSK Investigational Site, Valencia 46200, Spain
GSK Investigational Site, Vic 08500, Spain
GSK Investigational Site, Bangkok 10330, Thailand
GSK Investigational Site, Bangkok 10400, Thailand
GSK Investigational Site, Bangkok 10700, Thailand
GSK Investigational Site, Chiang mai 50200, Thailand
GSK Investigational Site, Patumtani 12121, Thailand
GSK Investigational Site, Birmingham, Alabama 35205, United States
GSK Investigational Site, Phoenix, Arizona 85032, United States
GSK Investigational Site, Phoenix, Arizona 85282, United States
GSK Investigational Site, Jonesboro, Arkansas 72401, United States
GSK Investigational Site, Little Rock, Arkansas 72205, United States
GSK Investigational Site, Anaheim, California 92805, United States
GSK Investigational Site, Long Beach, California 90813, United States
GSK Investigational Site, West Covina, California 91790, United States
GSK Investigational Site, Altamonte Springs, Florida 32701, United States
GSK Investigational Site, Miami Lakes, Florida 33014, United States
GSK Investigational Site, Miami, Florida 33184, United States
GSK Investigational Site, Naples, Florida 34102, United States
GSK Investigational Site, Tampa, Florida 33606, United States
GSK Investigational Site, Muncie, Indiana 47304-5547, United States
GSK Investigational Site, New Albany, Indiana 47150, United States
GSK Investigational Site, West Des Moines, Iowa 50265, United States
GSK Investigational Site, Wichita, Kansas 67205, United States
GSK Investigational Site, Louisville, Kentucky 40207, United States
GSK Investigational Site, Nicholasville, Kentucky 40356, United States
GSK Investigational Site, Annapolis, Maryland 21401, United States
GSK Investigational Site, Baltimore, Maryland 21201, United States
GSK Investigational Site, Frederick, Maryland 21702, United States
GSK Investigational Site, Kansas City, Missouri 64108, United States
GSK Investigational Site, Bellevue, Nebraska 68123, United States
GSK Investigational Site, Fremont, Nebraska 68025, United States
GSK Investigational Site, Lincoln, Nebraska 68504, United States
GSK Investigational Site, Lincoln, Nebraska 68506, United States
GSK Investigational Site, Omaha, Nebraska 68131, United States
GSK Investigational Site, Clyde, North Carolina 28721, United States
GSK Investigational Site, Holly Springs, North Carolina 27540, United States
GSK Investigational Site, Cleveland, Ohio 44106, United States
GSK Investigational Site, Cleveland, Ohio 44121, United States
GSK Investigational Site, Dayton, Ohio 45406, United States
GSK Investigational Site, Dayton, Ohio 45414, United States
GSK Investigational Site, Youngstown, Ohio 44514, United States
GSK Investigational Site, Youngstown, Ohio 44505, United States
GSK Investigational Site, Gresham, Oregon 97030, United States
GSK Investigational Site, Indiana, Pennsylvania 15701, United States
GSK Investigational Site, Johnstown, Pennsylvania 15904, United States
GSK Investigational Site, Charleston, South Carolina 29406, United States
GSK Investigational Site, Charleston, South Carolina 29414, United States
GSK Investigational Site, Houston, Texas 77087, United States
GSK Investigational Site, Waco, Texas 76710, United States
GSK Investigational Site, Layton, Utah 84041, United States
GSK Investigational Site, Springville, Utah 84663, United States
GSK Investigational Site, St. George, Utah 84790, United States
GSK Investigational Site, Midlothian, Virginia 23113, United States
GSK Investigational Site, Richmond, Virginia 23223, United States
GSK Investigational Site, Richmond, Virginia 23294, United States
GSK Investigational Site, Ellensburg, Washington 98926, United States