Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:6/30/2018
Start Date:November 9, 2012
End Date:April 16, 2015

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

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

The purpose of this study is to evaluate consistency in terms of the immune response to three
different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,
and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use
in the United States (US).

This study will evaluate the consistency of the immune response to three different lots of
GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine,
throughout this document) and compare its immunogenicity 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 INV_MMR vaccine will be given as
one of three consistency lots manufactured to target potencies designated as INV_MMR_L1,
INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated
COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR
vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort
only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.

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 only (i.e., no doses given
as Prevnar/Prevenar), with the 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 (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.

- 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.

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

- Inactivated influenza (Flu) vaccine and 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 prior to 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.

- 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. 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:

- Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior
vaccination should be with 3 doses of Prevnar 13 only).

- Child that previously received a fourth dose of any pneumococcal conjugate vaccine.
We found this trial at
69
sites
Syracuse, New York 13210
414
mi
from 43215
Syracuse, NY
Click here to add this to my saved trials
Ames, Iowa 50010
569
mi
from 43215
Ames, IA
Click here to add this to my saved trials
Anaheim, California 92807
1953
mi
from 43215
Anaheim, CA
Click here to add this to my saved trials
Augusta, Kansas 67010
766
mi
from 43215
Augusta, KS
Click here to add this to my saved trials
Barnwell, South Carolina 29812
473
mi
from 43215
Barnwell, SC
Click here to add this to my saved trials
Bossier City, Louisiana 71111
786
mi
from 43215
Bossier City, LA
Click here to add this to my saved trials
Boston, Massachusetts 02115
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Bristol, Tennessee 37620
237
mi
from 43215
Bristol, TN
Click here to add this to my saved trials
Bronx, New York 10461
486
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
Burke, Virginia 22015
317
mi
from 43215
Burke, VA
Click here to add this to my saved trials
Charlottesville, Virginia 22903
278
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
96
mi
from 43215
Cincinnati, OH
Click here to add this to my saved trials
Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
1161
mi
from 43215
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Maryland 21044
331
mi
from 43215
Columbia, MD
Click here to add this to my saved trials
Dalton, Georgia 30721
374
mi
from 43215
Dalton, GA
Click here to add this to my saved trials
Daly City, California 94015
2112
mi
from 43215
Daly City, CA
Click here to add this to my saved trials
Dothan, Alabama 36305
620
mi
from 43215
Dothan, AL
Click here to add this to my saved trials
Erie, Pennsylvania 16507
214
mi
from 43215
Erie, PA
Click here to add this to my saved trials
Erie, Pennsylvania 16507
214
mi
from 43215
Erie, PA
Click here to add this to my saved trials
Evergreen Park, Illinois 60805
272
mi
from 43215
Evergreen Park, IL
Click here to add this to my saved trials
Fall River, Massachusetts 02720
633
mi
from 43215
Fall River, MA
Click here to add this to my saved trials
Falls Church, Virginia 22042
319
mi
from 43215
Falls Church, VA
Click here to add this to my saved trials
Fayetteville, Arkansas 72703
659
mi
from 43215
Fayetteville, AR
Click here to add this to my saved trials
Fort Worth, Texas 76104
937
mi
from 43215
Fort Worth, TX
Click here to add this to my saved trials
Fresno, California 93720
1986
mi
from 43215
Fresno, CA
Click here to add this to my saved trials
Hayward, California 94545
2094
mi
from 43215
Hayward, CA
Click here to add this to my saved trials
Hermitage, Pennsylvania 16148
160
mi
from 43215
Hermitage, PA
Click here to add this to my saved trials
Houston, Texas 77030
995
mi
from 43215
Houston, TX
Click here to add this to my saved trials
Ithaca, New York 14850
379
mi
from 43215
Ithaca, NY
Click here to add this to my saved trials
Kansas City, Missouri 64128
616
mi
from 43215
Kansas City, MO
Click here to add this to my saved trials
Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
Click here to add this to my saved trials
Layton, Utah 84041
1515
mi
from 43215
Layton, UT
Click here to add this to my saved trials
League City, Texas 77573
994
mi
from 43215
League City, TX
Click here to add this to my saved trials
Los Gatos, California 95032
2094
mi
from 43215
Los Gatos, CA
Click here to add this to my saved trials
Louisville, Kentucky 40202
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
Madison, Wisconsin 53792
394
mi
from 43215
Madison, WI
Click here to add this to my saved trials
Marshfield, Wisconsin 54449
488
mi
from 43215
Marshfield, WI
Click here to add this to my saved trials
Mission Hills, California 91345
1977
mi
from 43215
Mission Hills, CA
Click here to add this to my saved trials
Nampa, Idaho 83686
1734
mi
from 43215
Nampa, ID
Click here to add this to my saved trials
Niles, Michigan 49120
212
mi
from 43215
Niles, MI
Click here to add this to my saved trials
Oakland, California 94611
2094
mi
from 43215
Oakland, CA
Click here to add this to my saved trials
Overland Park, Kansas 66210
626
mi
from 43215
Overland Park, KS
Click here to add this to my saved trials
Paramount, California 90723
1972
mi
from 43215
Paramount, CA
Click here to add this to my saved trials
Payson, Utah 84651
1512
mi
from 43215
Payson, UT
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
414
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85012
1660
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
Pleasanton, California 94588
2082
mi
from 43215
Pleasanton, CA
Click here to add this to my saved trials
Provo, Utah 84604
1506
mi
from 43215
Provo, UT
Click here to add this to my saved trials
Richmond, Virginia 23298
344
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
Roy, Utah 84067
1517
mi
from 43215
Roy, UT
Click here to add this to my saved trials
Sacramento, California 95815
2040
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
Sacramento, California 95815
2040
mi
from 43215
Sacramento, CA
Click here to add this to my saved trials
Saint George, Utah 84770
1655
mi
from 43215
Saint George, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84132
1511
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
Salt Lake City, Utah 84132
1511
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas 78258
1126
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
Santa Clara, California 95051
2092
mi
from 43215
Santa Clara, CA
Click here to add this to my saved trials
Seattle, Washington 98109
2007
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
Sellersville, Pennsylvania 18960
408
mi
from 43215
Sellersville, PA
Click here to add this to my saved trials
Stevensville, Michigan 49127
230
mi
from 43215
Stevensville, MI
Click here to add this to my saved trials
Syracuse, Utah 84075
1520
mi
from 43215
Syracuse, UT
Click here to add this to my saved trials
Tallinn, 13619
4443
mi
from 43215
Tallinn,
Click here to add this to my saved trials
Tomball, Texas 77375
984
mi
from 43215
Tomball, TX
Click here to add this to my saved trials
Topeka, Kansas 66604
679
mi
from 43215
Topeka, KS
Click here to add this to my saved trials
Walnut Creek, California 94596
2084
mi
from 43215
Walnut Creek, CA
Click here to add this to my saved trials
Warwick, Rhode Island 02888
618
mi
from 43215
Warwick, RI
Click here to add this to my saved trials
West Jordan, Utah 84088
1519
mi
from 43215
West Jordan, UT
Click here to add this to my saved trials
Wichita, Kansas 67207
780
mi
from 43215
Wichita, KS
Click here to add this to my saved trials