Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:4 - 6
Updated:10/14/2017
Start Date:June 21, 2012
End Date:November 9, 2015

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Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®)
in the US by generating immunogenicity and safety data in contrast to the US standard of
care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six
years of age.

The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred
to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine
(Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.

The Inv_MMR vaccine will be administered as a second dose to children who already received a
first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely
co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or
Varivax®), some children will receive one dose of these vaccines along with either of the MMR
vaccines.

Inclusion Criteria:

- Subjects who the investigator believes that they and/or their parent(s) or LAR/s can
and will comply with the requirements of the protocol.

- Male or female subjects 4 to 6 years of age at the time of vaccination.

- Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent
will be obtained from subjects in line with local rules and regulations).

- Subjects in stable health as determined by investigator's physical examination and
assessment of subjects' medical history.

- Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the
second year of life.

- For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:

- subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for
the first three doses and INFANRIX® for the fourth dose of the DTaP-containing
vaccine.

- subjects received a first dose of VV in the second year of life.

Exclusion Criteria:

- Child in care.

- Use of any investigational or non-registered product other than the study vaccine
during the period starting 30 days before the day of study vaccination/s or planned
during the entire study period.

- Previous vaccination with a second dose of measles, mumps, rubella containing
vaccine/s.

- Chronic administration of immunosuppressants or other immune-modifying drugs during
the period starting 180 days prior to Day 0 or any planned administration of
immunosuppressive and immune-modifying drugs during the entire study. Inhaled and
topical steroids are allowed.

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

- Planned administration/ administration of a vaccine not foreseen by the study protocol
during the period starting 30 days prior to the study vaccination/s and ending 42 days
after the vaccination/s (at Visit 2), with the exception of live intranasal or
inactivated influenza (flu) vaccine, which may be given at any time during the study,
including the day of study vaccination/s. Inactivated influenza vaccine must be
administered at a different location from the study vaccine. Any age appropriate
vaccine may be given starting at Visit 2, and anytime thereafter.

- Concurrently participating in another clinical study, at any time during the study
period, in which the subject has been or will be exposed to an investigational or a
non-investigational product.

- History of measles, mumps, and/or rubella disease.

- Known exposure to measles, mumps and/or rubella during the period starting 30 days
prior to enrollment.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccine(s), including systemic hypersensitivity to neomycin 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) measured 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 according to the subject's medical history.

- Any other condition which, in the opinion of the investigator, prevents the subject
from participating in the study.

In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:

- Previous vaccination with a second dose of varicella-containing vaccine.

- Receipt of any varicella-containing vaccine during the period starting 90 days before
the day of study vaccination.

- History of varicella/zoster disease.

- Known exposure to varicella/zoster during the period starting 30 days prior to
enrollment.

- History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.

- Vaccination against diphtheria, tetanus, pertussis or polio given after the second
year of life.

- Occurrence of transient thrombocytopenia or neurological complications following an
earlier immunization against diphtheria and/or tetanus toxoids.

- Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F)
during the period starting 48 hours not due to another identifiable cause, collapse or
shock-like state during the period starting 48 hours, persistent, inconsolable crying
lasting three hours or more within 48 hours, seizures with or without fever occurring
during the period starting three days, or encephalopathy of unknown aetiology
occurring during the period starting 7 days of a previous administration of DTP
vaccine.

- Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
We found this trial at
52
sites
Provo, Utah 84604
761
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Provo, UT
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Altamonte Springs, Florida 32714
1134
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Altamonte Springs, FL
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Anaheim, California 92807
1148
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Anaheim, CA
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?
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Ansan,
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Asheboro, North Carolina 27203
1006
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Asheboro, NC
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Augusta, Kansas 67010
46
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Augusta, KS
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Baldwin Park, California 91706
1152
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Bardstown, Kentucky 40004
674
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Bardstown, KY
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Benton, Arkansas 72019
365
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Benton, AR
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Birmingham, Alabama 35249
676
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Birmingham, AL
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Burke, Virginia 22015
1114
mi
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Burke, VA
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Charleston, South Carolina 29425
1063
mi
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Charleston, SC
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Charlottesville, Virginia 22903
1053
mi
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Charlottesville, VA
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Cheraw, South Carolina 29520
1020
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Cheraw, SC
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Cincinnati, Ohio 45229
727
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Cincinnati, OH
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Cleveland, Ohio 44195
898
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Cleveland, OH
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Colorado Springs, Colorado 80910
383
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Colorado Springs, CO
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Columbia, Maryland 21044
1134
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Columbia, MD
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Daly City, California 94015
1344
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Daly City, CA
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Dayton, Ohio 45420
749
mi
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Dayton, OH
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Dayton, Ohio 45420
749
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Dayton, OH
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Erie, Pennsylvania 16507
984
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Erie, PA
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Fall River, Massachusetts 02720
1439
mi
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Fall River, MA
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Fayetteville, Arkansas 72703
234
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Fayetteville, AR
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Fresno, California 93720
1205
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Fresno, CA
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Gresham, Oregon 97030
1371
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Gresham, OR
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Hayward, California 94545
1324
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Hayward, CA
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Hilliard, Ohio 43026
803
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Hilliard, OH
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Houston, Texas 77030
572
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Houston, TX
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Huntington, West Virginia 25701
836
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Indianapolis, Indiana 46202
643
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Indianapolis, IN
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Little Rock, Arkansas 72205
368
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Little Rock, AR
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Marietta, Georgia 30060
788
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Marietta, GA
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Monroe, Wisconsin 53566
546
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Monroe, WI
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Nampa, Idaho 83686
1057
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Nampa, ID
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Newton, Kansas 67114
33
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Newton, KS
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Oakland, California 94611
1327
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Oakland, CA
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Pleasanton, California 94588
1312
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Raleigh, North Carolina 27614
1066
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Raleigh, NC
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Rapid City, South Dakota 57702
520
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Rapid City, SD
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Sacramento, California 95815
1280
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Sacramento, CA
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Sacramento, California 95815
1280
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Saint George, Utah 84770
864
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Saint George, UT
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Salt Lake City, Utah 84132
777
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Santa Clara, California 95051
1319
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Shreveport, Louisiana 71103
429
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Shreveport, LA
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South Jordan, Utah 84095
779
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South Jordan, UT
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The Bronx, New York 10457
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Tomball, Texas 77375
543
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Tucson, Arizona 85724
833
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Walnut Creek, California 94596
1317
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Woodstock, Georgia 30189
784
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Woodstock, GA
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