Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:7/5/2018
Start Date:August 25, 2014
End Date:December 22, 2015

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Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved
for use in the US in healthy children 12 to 15 months of age.

This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR
vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in
comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR
vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR
used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout
the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended
to support licensure of GSK's MMR vaccine in the US.

All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing
vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At
the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to
participants enrolled in selected non-US countries if local health departments do not
routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and
varicella vaccine is not part of the study procedures.

Inclusion Criteria:

- Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday
until the day before age 16 months) at the time of vaccination.

- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
of the investigator, 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: a child who received all routine vaccinations as per ACIP
recommendations prior to study entry: completion of hepatitis B and rotavirus series
and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus,
Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant
series of Prevnar 13 should be completed at least 60 days prior to study vaccination.

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) during the period starting 30 days before the day of study
vaccination (i.e., 30 days prior to Day 0) 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 (pharmaceutical
product or device).

- Chronic administration (defined as 14 or more consecutive days) of immunosuppressants,
or other immune-modifying drugs during the period starting 180 days prior to the study
vaccination at Visit 1 or any planned administration of immunosuppressive and
immune-modifying drugs during the entire study.

- For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.

- 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 the day of study vaccination at Visit 1
and ending at Visit 2. Please Note:

- Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b
conjugate vaccine (Hib) vaccines may be given at any time, including the day of
study vaccination (Flu and Hib vaccines must be administered at a different
location than the study vaccine/s).

- Any other age appropriate vaccine may be given starting at Visit 2 and anytime
thereafter.

- Administration of immunoglobulins and/or any blood products during the period starting
180 days before the study vaccination at Visit 1 or planned administration from the
date of vaccination through the immunogenicity evaluation at Visit 2.

- History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.

- Known exposure to measles, mumps, rubella and/or varicella/zoster during the period
starting within 30 days prior to 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 (no laboratory testing required).

- Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms
affecting the bone marrow or lymphatic systems.

- 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.

- 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
≥38.0°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 PCV-13
vaccine.
We found this trial at
85
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Watertown, South Dakota 57201
793
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Watertown, SD
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Anaheim, California 92807
1953
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Asheboro, North Carolina 27203
341
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Augusta, Kansas 67010
766
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Augusta, KS
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Baldwin Park, California 91706
1956
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Baltimore, Maryland 21201
343
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Baltimore, MD
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Bardstown, Kentucky 40004
198
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Binghamton, New York 13901
398
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Birmingham, Alabama 35249
493
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Boone, North Carolina 28607
269
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Bossier City, Louisiana 71111
786
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Bossier City, LA
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Boston, Massachusetts 02115
643
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Boston, MA
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Boston, Massachusetts 02115
643
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Boston, MA
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Charleston, South Carolina 29425
524
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Charleston, SC
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Charlottesville, Virginia 22903
278
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Charlottesville, VA
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Cheraw, South Carolina 29520
402
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Cheraw, SC
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Cleveland, Ohio 44195
129
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Cleveland, OH
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Cleveland, Ohio 44195
129
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Clyde, North Carolina 28721
306
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Clyde, NC
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Colorado Springs, Colorado 80910
1161
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Columbia, Maryland 21044
331
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Columbus, Ohio 43219
7
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Daly City, California 94015
2112
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Dayton, Ohio 45420
60
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Dayton, Ohio 45420
60
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Dinuba, California 93618
1973
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Downey, California 90241
1969
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Downey, CA
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Ellensburg, Washington 98926
1922
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Erie, Pennsylvania 16507
214
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Fayetteville, Arkansas 72703
659
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Frederick, Maryland 21702
300
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Fresno, California 93720
1986
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Hayward, California 94545
2094
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Huntington, West Virginia 25701
111
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Jonesboro, Arkansas 72401
506
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Kansas City, Missouri 64128
616
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Kingsport, Tennessee 37660
237
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Layton, Utah 84041
1515
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League City, Texas 77573
994
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Lincoln, Nebraska 68510
716
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Lincoln, Nebraska 68510
716
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Lincoln, Nebraska 68510
716
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Mandan, North Dakota 58501
1011
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Marshfield, Wisconsin 54449
488
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Metairie, Louisiana 70006
795
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Miami Lakes, Florida 33014
983
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Monroe, Wisconsin 53566
388
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Murray, Utah 84107
1514
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Nampa, Idaho 83686
1734
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Newton, Kansas 67114
779
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Niles, Michigan 49120
212
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Norwich, Connecticut 06360
582
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Oakland, California 94611
2094
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Oakland, California 94611
2094
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Omaha, Nebraska 68131
683
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Orem, Utah 84058
1508
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Paramount, California 90723
1972
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Payson, Utah 84651
1512
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Pleasanton, California 94588
2082
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Provo, Utah 84604
1506
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Raleigh, North Carolina 27614
366
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Roseville, California 95678
2029
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Roy, Utah 84067
1517
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Sacramento, California 95815
2040
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Sacramento, California 95815
2040
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Sacramento, California 95815
2040
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Saint George, Utah 84770
1655
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Salt Lake City, Utah 84132
1511
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San Jose, California 95116
2085
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Santa Clara, California 95051
2092
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Sellersville, Pennsylvania 18960
408
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Sioux Falls, South Dakota 57108
744
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Sioux Falls, South Dakota 57108
744
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South Jordan, Utah 84095
1517
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Spartanburg, South Carolina 29303
349
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Stevensville, Michigan 49127
230
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Syracuse, New York 13210
414
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Syracuse, New York 13210
414
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Syracuse, Utah 84075
1520
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4541
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Tartu,
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Tomball, Texas 77375
984
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Topeka, Kansas 66604
679
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Tucson, Arizona 85724
1639
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Walnut Creek, California 94596
2084
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West Jordan, Utah 84088
1519
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