Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:June 3, 2009
End Date:June 18, 2012

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A Phase II, Randomized, Observer Blind, Controlled, Multicenter Study to Assess Immunogenicity and Antibody Persistence Following Vaccination With GSK's Candidate Combined Measles, Mumps, and Rubella Vaccine (MMR) Versus M-M-R® II as a First Dose, Both Administered Subcutaneously at 12-15 Months of Age, Concomitantly With Hepatitis A Vaccine (HAV), Varicella Vaccine (VV) and Pneumococcal Conjugate Vaccine (PCV) But at Separate Sites.

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines
(manufactured by GSK and Merck and Company ) in terms of the immune response elicited and
safety with a six month follow-up after first vaccination. Additionally, antibody persistence
will be assessed one and two years after administration of MMR vaccine.

The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.


Inclusion Criteria:

- Subjects for whom the investigator believes their parents/guardians can and will
comply with the requirements of the protocol (e.g. completion of the diary cards,
return for follow-up visits) should be enrolled in the study.

- Male or female between 12 and 15 months of age (e.g. from age 12 months until the day
before age 16 months) at the time of vaccination.

- Written informed consent obtained from the parent/guardian of the subject.

- Healthy subjects as established by medical history and clinical examination before
entering into the study.

- Have previously received three doses of 7-valent pneumococcal conjugate vaccine within
the first year of life with the third dose administered at least 30 days prior to
enrolment and vaccination with study vaccines.

Exclusion Criteria:

- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.

- 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 (pharmaceutical product or device).

- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.

- Planned administration/ administration of a vaccine not foreseen by the study protocol
from 30 days prior to vaccination until 42 days after vaccination, except for
influenza vaccine and Hib vaccine.

- Previous vaccination against measles, mumps, rubella and/or varicella.

- Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal
conjugate vaccine.

- History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases.

- Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior
to the start of the study.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required), including
human immunodeficiency virus (HIV) infection.

- A family history of congenital or hereditary immunodeficiency.

- History of allergic disease or reactions likely to be exacerbated by any component of
the vaccines.

- Hypersensitivity to latex

- Major congenital defects or serious chronic illness.

- History of any neurologic disorders or seizures, including febrile seizures.

- Acute disease at the time of enrolment.

- Administration of polyclonal immunoglobulins and/or any blood products during the six
months before entering the study or planned administration during the study period.
We found this trial at
46
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Saint George, Utah 84770
1655
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Saint George, UT
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Altamonte Springs, Florida 32714
786
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Anaheim, California 92807
1953
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Arkansas City, Kansas 67005
782
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Baltimore, Maryland 21201
343
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Baltimore, MD
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Bardstown, Kentucky 40004
198
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Bardstown, KY
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Bayamon, 00959
1797
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Bayamon,
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Bossier City, Louisiana 71111
786
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Bossier City, LA
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Bristol, Tennessee 37620
237
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Bristol, TN
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Cary, North Carolina 27518
373
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Cary, NC
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Charleston, South Carolina 29425
524
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Charleston, SC
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Cincinnati, Ohio 45229
96
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Cincinnati, OH
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Conway, Arkansas 72034
615
mi
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Conway, AR
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Corpus Christi, Texas 78405
1177
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Corpus Christi, TX
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Dalton, Georgia 30721
374
mi
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Dalton, GA
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Dayton, Ohio 45420
60
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Dayton, OH
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DeKalb, Illinois 60115
328
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DeKalb, IL
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Downey, California 90241
1969
mi
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Downey, CA
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East Norriton, Pennsylvania 19401
406
mi
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East Norriton, PA
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Fall River, Massachusetts 02720
633
mi
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Fall River, MA
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Fresno, California 93720
1986
mi
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Fresno, CA
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Great Falls, Montana 59405
1493
mi
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Great Falls, MT
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Gresham, Oregon 97030
2014
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Gresham, OR
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Henderson, Nevada 89052
1755
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Henderson, NV
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Huntington, West Virginia 25701
111
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Huntington, WV
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Huntington Beach, California 92647
1968
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Huntington Beach, CA
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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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Kingsport, Tennessee 37660
237
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Kingsport, TN
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Layton, Utah 84041
1515
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Layton, UT
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Little Rock, Arkansas 72205
625
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Little Rock, AR
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Marietta, Georgia 30060
423
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Marietta, GA
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Metairie, Louisiana 70006
795
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Metairie, LA
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Nampa, Idaho 83686
1734
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Nampa, ID
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Paramount, California 90723
1972
mi
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Paramount, CA
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Provo, Utah 84604
1506
mi
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Provo, UT
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Raleigh, North Carolina 27614
366
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Raleigh, NC
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5 Crescent Drive
Rydal, Pennsylvania 19046
415
mi
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Rydal, PA
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Santa Ana, California 92705
1960
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Santa Ana, CA
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Springville, Utah 84663
1505
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Springville, UT
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Tulsa, Oklahoma 74105
752
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Tulsa, OK
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Tuscaloosa, Alabama 35401
534
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Tuscaloosa, AL
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Utica, New York 13502
457
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Utica, NY
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Virginia Beach, Virginia 23456
439
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Virginia Beach, VA
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West Covina, California 91790
1955
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West Covina, CA
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West Jordan, Utah 84088
1519
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West Jordan, UT
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