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

Completed · Phase 3

Conditions studied: Measles, Mumps, Rubella, Measles-Mumps-Rubella Vaccine

In brief

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).

Key facts

Study ID

NCT01681992

Run by

GlaxoSmithKline

People needed

4538

Starts

2012-10-10

Expected to finish

2015-08-18

Last updated by the study team

2021-01-07

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — West Covina, California, United States
• GSK Investigational Site — Altamonte Springs, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami Lakes, Florida, United States
• GSK Investigational Site — Naples, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Muncie, Indiana, United States
• GSK Investigational Site — New Albany, Indiana, United States
• GSK Investigational Site — West Des Moines, Iowa, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Annapolis, Maryland, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Frederick, Maryland, United States
• GSK Investigational Site — Kansas City, Missouri, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Lincoln, Nebraska, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Clyde, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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