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

Use our guide to learn which trials are right for you!

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
sites
Anaheim, California 92807
981
mi
from 98109
Anaheim, CA
Click here to add this to my saved trials
Asheboro, North Carolina 27203
2310
mi
from 98109
Asheboro, NC
Click here to add this to my saved trials
Augusta, Kansas 67010
1451
mi
from 98109
Augusta, KS
Click here to add this to my saved trials
Baldwin Park, California 91706
963
mi
from 98109
Baldwin Park, CA
Click here to add this to my saved trials
Baltimore, Maryland 21201
2327
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
Bardstown, Kentucky 40004
1968
mi
from 98109
Bardstown, KY
Click here to add this to my saved trials
Binghamton, New York 13901
2270
mi
from 98109
Binghamton, NY
Click here to add this to my saved trials
Birmingham, Alabama 35249
2072
mi
from 98109
Birmingham, AL
Click here to add this to my saved trials
Boone, North Carolina 28607
2204
mi
from 98109
Boone, NC
Click here to add this to my saved trials
Bossier City, Louisiana 71111
1821
mi
from 98109
Bossier City, LA
Click here to add this to my saved trials
Boston, Massachusetts 02115
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02115
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
Charleston, South Carolina 29425
2422
mi
from 98109
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22903
2285
mi
from 98109
Charlottesville, VA
Click here to add this to my saved trials
Cheraw, South Carolina 29520
2346
mi
from 98109
Cheraw, SC
Click here to add this to my saved trials
Cleveland, Ohio 44195
2024
mi
from 98109
Cleveland, OH
Click here to add this to my saved trials
Cleveland, Ohio 44195
2024
mi
from 98109
Cleveland, OH
Click here to add this to my saved trials
Clyde, North Carolina 28721
2173
mi
from 98109
Clyde, NC
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
1070
mi
from 98109
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Maryland 21044
2318
mi
from 98109
Columbia, MD
Click here to add this to my saved trials
Columbus, Ohio 43219
2009
mi
from 98109
Columbus, OH
Click here to add this to my saved trials
Daly City, California 94015
687
mi
from 98109
Daly City, CA
Click here to add this to my saved trials
Dayton, Ohio 45420
1964
mi
from 98109
Dayton, OH
Click here to add this to my saved trials
Dayton, Ohio 45420
1964
mi
from 98109
Dayton, OH
Click here to add this to my saved trials
Dinuba, California 93618
780
mi
from 98109
Dinuba, CA
Click here to add this to my saved trials
Downey, California 90241
971
mi
from 98109
Downey, CA
Click here to add this to my saved trials
Ellensburg, Washington 98926
94
mi
from 98109
Ellensburg, WA
Click here to add this to my saved trials
Erie, Pennsylvania 16507
2075
mi
from 98109
Erie, PA
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
1643
mi
from 98109
Fayetteville, AR
Click here to add this to my saved trials
Frederick, Maryland 21702
2287
mi
from 98109
Frederick, MD
Click here to add this to my saved trials
Fresno, California 93720
755
mi
from 98109
Fresno, CA
Click here to add this to my saved trials
Hayward, California 94545
692
mi
from 98109
Hayward, CA
Click here to add this to my saved trials
Huntington, West Virginia 25701
2087
mi
from 98109
Huntington, WV
Click here to add this to my saved trials
Jonesboro, Arkansas 72401
1806
mi
from 98109
Jonesboro, AR
Click here to add this to my saved trials
Kansas City, Missouri 64128
1506
mi
from 98109
Kansas City, MO
Click here to add this to my saved trials
Kingsport, Tennessee 37660
2150
mi
from 98109
Kingsport, TN
Click here to add this to my saved trials
Layton, Utah 84041
683
mi
from 98109
Layton, UT
Click here to add this to my saved trials
League City, Texas 77573
1915
mi
from 98109
League City, TX
Click here to add this to my saved trials
Lincoln, Nebraska 68510
1350
mi
from 98109
Lincoln, NE
Click here to add this to my saved trials
Lincoln, Nebraska 68510
1350
mi
from 98109
Lincoln, NE
Click here to add this to my saved trials
Lincoln, Nebraska 68510
1350
mi
from 98109
Lincoln, NE
Click here to add this to my saved trials
Mandan, North Dakota 58501
1004
mi
from 98109
Mandan, ND
Click here to add this to my saved trials
Marshfield, Wisconsin 54449
1542
mi
from 98109
Marshfield, WI
Click here to add this to my saved trials
Metairie, Louisiana 70006
2090
mi
from 98109
Metairie, LA
Click here to add this to my saved trials
Miami Lakes, Florida 33014
2720
mi
from 98109
Miami Lakes, FL
Click here to add this to my saved trials
Monroe, Wisconsin 53566
1619
mi
from 98109
Monroe, WI
Click here to add this to my saved trials
Murray, Utah 84107
706
mi
from 98109
Murray, UT
Click here to add this to my saved trials
Nampa, Idaho 83686
397
mi
from 98109
Nampa, ID
Click here to add this to my saved trials
Newton, Kansas 67114
1420
mi
from 98109
Newton, KS
Click here to add this to my saved trials
Niles, Michigan 49120
1798
mi
from 98109
Niles, MI
Click here to add this to my saved trials
Norwich, Connecticut 06360
2465
mi
from 98109
Norwich, CT
Click here to add this to my saved trials
Oakland, California 94611
677
mi
from 98109
Oakland, CA
Click here to add this to my saved trials
Oakland, California 94611
677
mi
from 98109
Oakland, CA
Click here to add this to my saved trials
Omaha, Nebraska 68131
1365
mi
from 98109
Omaha, NE
Click here to add this to my saved trials
Orem, Utah 84058
731
mi
from 98109
Orem, UT
Click here to add this to my saved trials
Paramount, California 90723
974
mi
from 98109
Paramount, CA
Click here to add this to my saved trials
Payson, Utah 84651
743
mi
from 98109
Payson, UT
Click here to add this to my saved trials
Pleasanton, California 94588
687
mi
from 98109
Pleasanton, CA
Click here to add this to my saved trials
Provo, Utah 84604
736
mi
from 98109
Provo, UT
Click here to add this to my saved trials
Raleigh, North Carolina 27614
2356
mi
from 98109
Raleigh, NC
Click here to add this to my saved trials
Roseville, California 95678
615
mi
from 98109
Roseville, CA
Click here to add this to my saved trials
Roy, Utah 84067
676
mi
from 98109
Roy, UT
Click here to add this to my saved trials
Sacramento, California 95815
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95815
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95815
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
Saint George, Utah 84770
852
mi
from 98109
Saint George, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84132
702
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
San Jose, California 95116
710
mi
from 98109
San Jose, CA
Click here to add this to my saved trials
Santa Clara, California 95051
710
mi
from 98109
Santa Clara, CA
Click here to add this to my saved trials
Sellersville, Pennsylvania 18960
2353
mi
from 98109
Sellersville, PA
Click here to add this to my saved trials
Sioux Falls, South Dakota 57108
1266
mi
from 98109
Sioux Falls, SD
Click here to add this to my saved trials
Sioux Falls, South Dakota 57108
1266
mi
from 98109
Sioux Falls, SD
Click here to add this to my saved trials
South Jordan, Utah 84095
709
mi
from 98109
South Jordan, UT
Click here to add this to my saved trials
Spartanburg, South Carolina 29303
2240
mi
from 98109
Spartanburg, SC
Click here to add this to my saved trials
Stevensville, Michigan 49127
1781
mi
from 98109
Stevensville, MI
Click here to add this to my saved trials
Syracuse, New York 13210
2233
mi
from 98109
Syracuse, NY
Click here to add this to my saved trials
Syracuse, New York 13210
2233
mi
from 98109
Syracuse, NY
Click here to add this to my saved trials
Syracuse, Utah 84075
678
mi
from 98109
Syracuse, UT
Click here to add this to my saved trials
4904
mi
from 98109
Tartu,
Click here to add this to my saved trials
Tomball, Texas 77375
1863
mi
from 98109
Tomball, TX
Click here to add this to my saved trials
Topeka, Kansas 66604
1453
mi
from 98109
Topeka, KS
Click here to add this to my saved trials
Tucson, Arizona 85724
1219
mi
from 98109
Tucson, AZ
Click here to add this to my saved trials
Walnut Creek, California 94596
673
mi
from 98109
Walnut Creek, CA
Click here to add this to my saved trials
Watertown, South Dakota 57201
1214
mi
from 98109
Watertown, SD
Click here to add this to my saved trials
West Jordan, Utah 84088
707
mi
from 98109
West Jordan, UT
Click here to add this to my saved trials