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



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:8/19/2018
Start Date:October 10, 2012
End Date:August 18, 2015

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Immunogenicity and Safety Study of GSK Biologicals' Priorix Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life

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).

This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center,
multi-country study with four parallel groups. This study will evaluate the immunogenicity
and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR
vaccine, throughout this document) in contrast 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 first dose of this two-dose study is designed to
establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given
as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a
mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of
these Inv_MMR groups will have a potency within the release range of the marketed vaccine.
The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be
analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered
with Varivax, Havrix and (in the US sub-cohort only) Prevnar 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 with 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 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.
We found this trial at
52
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Springville, Utah 84663
1505
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Springville, UT
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Altamonte Springs, Florida 32714
786
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Anaheim, California 92807
1953
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Anaheim, CA
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Annapolis, Maryland 21401
354
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Annapolis, MD
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Baltimore, Maryland 21201
343
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Baltimore, MD
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Bellevue, Nebraska 68123
680
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Bellevue, NE
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Benesov, 25601
155
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Benesov,
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Birmingham, Alabama 35249
493
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Birmingham, AL
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Charleston, South Carolina 29425
524
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Charleston, SC
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Charleston, South Carolina 29425
524
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Charleston, 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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Cleveland, OH
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Clyde, North Carolina 28721
306
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Clyde, NC
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Dayton, Ohio 45420
60
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Dayton, OH
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Dayton, Ohio 45420
60
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Dayton, OH
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Ellensburg, Washington 98926
1922
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Ellensburg, WA
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Frederick, Maryland 21702
300
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Frederick, MD
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Fremont, Nebraska 68025
712
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Fremont, NE
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Gresham, Oregon 97030
2014
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Gresham, OR
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Holly Springs, North Carolina 27540
375
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Holly Springs, NC
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Houston, Texas 77030
995
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Houston, TX
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Indiana, Pennsylvania 15701
208
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Indiana, PA
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Johnstown, Pennsylvania 15904
222
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Johnstown, PA
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Jonesboro, Arkansas 72401
506
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Jonesboro, AR
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Kansas City, Missouri 64128
616
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Kansas City, MO
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Layton, Utah 84041
1515
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Lincoln, Nebraska 68510
716
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Lincoln, NE
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Lincoln, Nebraska 68510
716
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Lincoln, NE
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Little Rock, Arkansas 72205
625
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Long Beach, California 90813
1976
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Long Beach, CA
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Louisville, Kentucky 40202
188
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Louisville, KY
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Miami, Florida 33136
992
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Miami, FL
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Miami Lakes, Florida 33014
983
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Miami Lakes, FL
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Midlothian, Virginia 23114
335
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Midlothian, VA
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Muncie, Indiana 47304
125
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Muncie, IN
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Naples, Florida 34102
958
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Naples, FL
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New Albany, Indiana 47150
189
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Nicholasville, Kentucky 40356
166
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Omaha, Nebraska 68131
683
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Phoenix, Arizona 85012
1660
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Phoenix, Arizona 85012
1660
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Richmond, Virginia 23298
344
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Richmond, VA
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Richmond, Virginia 23298
344
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Saint George, Utah 84770
1655
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Tampa, Florida 33612
823
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Toledo, Ohio 43608
121
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Waco, Texas 76712
987
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West Covina, California 91790
1955
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West Des Moines, Iowa 50265
570
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Wichita, Kansas 67207
780
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Youngstown, Ohio 44501
147
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Youngstown, Ohio 44501
147
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Youngstown, OH
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