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

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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
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Syracuse, Utah 84075
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Ames, Iowa 50010
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Anaheim, California 92807
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Augusta, Kansas 67010
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Barnwell, South Carolina 29812
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Bossier City, Louisiana 71111
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Boston, Massachusetts 02115
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Bristol, Tennessee 37620
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Bronx, New York 10461
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Burke, Virginia 22015
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Charlottesville, Virginia 22903
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Cincinnati, Ohio 45229
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Cleveland, Ohio 44195
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Colorado Springs, Colorado 80910
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Columbia, Maryland 21044
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Dalton, Georgia 30721
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Daly City, California 94015
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Dothan, Alabama 36305
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Erie, Pennsylvania 16507
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Erie, Pennsylvania 16507
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Evergreen Park, Illinois 60805
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Fall River, Massachusetts 02720
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Falls Church, Virginia 22042
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Fayetteville, Arkansas 72703
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Fort Worth, Texas 76104
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Fresno, California 93720
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Hayward, California 94545
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Hermitage, Pennsylvania 16148
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Houston, Texas 77030
572
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Ithaca, New York 14850
1168
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Kansas City, Missouri 64128
199
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Kingsport, Tennessee 37660
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Layton, Utah 84041
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League City, Texas 77573
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Los Gatos, California 95032
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Madison, Wisconsin 53792
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Marshfield, Wisconsin 54449
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Mission Hills, California 91345
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Nampa, Idaho 83686
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Niles, Michigan 49120
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Oakland, California 94611
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Overland Park, Kansas 66210
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Paramount, California 90723
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Payson, Utah 84651
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Philadelphia, Pennsylvania 19104
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Phoenix, Arizona 85012
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Pleasanton, California 94588
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Provo, Utah 84604
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Richmond, Virginia 23298
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Roy, Utah 84067
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Sacramento, California 95815
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Saint George, Utah 84770
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Salt Lake City, Utah 84132
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Santa Clara, California 95051
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Stevensville, Michigan 49127
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Syracuse, New York 13210
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Tallinn, 13619
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Tomball, Texas 77375
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Walnut Creek, California 94596
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Warwick, Rhode Island 02888
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West Jordan, Utah 84088
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Wichita, Kansas 67207
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