Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:8/2/2018
Start Date:October 6, 2003
End Date:June 9, 2009

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

Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age

This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose
inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a
varicella (chickenpox) vaccine in children as young as 15 months of age.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.

An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The
three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II
and Varivax™ followed by Havrix™ one month later.

Inclusion Criteria:

- Subjects whose parents/guardians are believed by the investigator to be willing to
comply with the requirements of the protocol

- A male or female child 12 and 13 months of age at the time of entry into the
Enrollment Phase

- Written informed consent obtained from the parents or guardian of the subject,

- Free of obvious health problems as established by medical history and history-directed
physical examination before entering into the study, and

- Parents/guardian of the subject must have a telephone or be able to be contacted by
telephone

Exclusion Criteria:

- Use of any investigational or non-registered drug or vaccine other than the study
vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use
during the study period, Chronic administration (defined as more than 14 days) of
immuno-suppressant or other immune-modifying drugs within six months prior to
vaccination or planned administration at any time during the study period. (For
corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled,
nasal and topical steroids are allowed.) Planned administration or administration of
any vaccine not foreseen by the study protocol during the period 31 days before and 31
days after each dose of study vaccine(s).

- Previous vaccination against hepatitis A,

- History of hepatitis A,

- Known exposure to hepatitis A,

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

- History of measles, mumps, rubella and/or varicella,

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

- Planned chronic use of salicylates during the 6-week period following administration
of the doses of study vaccine(s),

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
human immunodeficiency virus (HIV) infection,

- A family history of congenital, hereditary or infectious immunodeficiency or parental
risk factors for HIV infection,

- History of allergic disease/reactions or hypersensitivity likely to be exacerbated by
any component of HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin
and gelatin,

- History of anaphylactic or anaphylactoid reactions to egg proteins,

- History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the
rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural
latex rubber.

- Major congenital defects or serious chronic illness,

- Active untreated tuberculosis,

- History of significant blood dyscrasias

- History of any neurologic disorder (a history of febrile seizures not associated with
an underlying neurological disorder does not exclude the subject)

- Acute disease at the time of vaccination

- Administration of immunoglobulins and/or any blood products within three months prior
to the first dose of study vaccine or planned administration at any time during the
entire study period
We found this trial at
40
sites
Pittsburgh, Pennsylvania 15213
165
mi
from 43215
Pittsburgh, PA
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Albany, New York 12206
514
mi
from 43215
Albany, NY
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Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Baltimore, Maryland 21201
343
mi
from 43215
Baltimore, MD
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1000 GSK Drive
Beaver Falls, Pennsylvania 15010
154
mi
from 43215
Beaver Falls, PA
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Bossier City, Louisiana 71111
786
mi
from 43215
Bossier City, LA
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Bristol, Tennessee 37620
237
mi
from 43215
Bristol, TN
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Brooklyn, New York 11215
478
mi
from 43215
Brooklyn, NY
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Cabot, Arkansas 72023
?
mi
from 43215
Cabot, AR
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Cleveland, Ohio 44195
129
mi
from 43215
Cleveland, OH
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Henderson, Nevada 89052
1755
mi
from 43215
Henderson, NV
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Huntington Beach, California 92647
1968
mi
from 43215
Huntington Beach, CA
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Jacksonville, Florida 32207
672
mi
from 43215
Jacksonville, FL
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Jonesboro, Arkansas 72401
506
mi
from 43215
Jonesboro, AR
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Kingsport, Tennessee 37660
237
mi
from 43215
Kingsport, TN
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Las Vegas, Nevada 89102
1759
mi
from 43215
Las Vegas, NV
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Layton, Utah 84041
1515
mi
from 43215
Layton, UT
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Lexington, Kentucky 40504
156
mi
from 43215
Lexington, KY
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Lumberton, North Carolina 28358
?
mi
from 43215
Lumberton, NC
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Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
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Marshfield, Wisconsin 54449
488
mi
from 43215
Marshfield, WI
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Norfolk, Virginia 23502
426
mi
from 43215
Norfolk, VA
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Norristown, Pennsylvania 19401
406
mi
from 43215
Norristown, PA
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North Little Rock, Arkansas 72117
621
mi
from 43215
North Little Rock, AR
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Norwich, Connecticut 06360
582
mi
from 43215
Norwich, CT
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Oakland, California 94611
2094
mi
from 43215
Oakland, CA
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Rochester, New York 14642
354
mi
from 43215
Rochester, NY
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Rolling Hills Estates, California 90274
1985
mi
from 43215
Rolling Hills Estates, CA
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5 Crescent Drive
Rydal, Pennsylvania 19046
415
mi
from 43215
Rydal, PA
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San Antonio, Texas 78258
1126
mi
from 43215
San Antonio, TX
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Sellersville, Pennsylvania 18960
408
mi
from 43215
Sellersville, PA
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South Jordan, Utah 84095
1517
mi
from 43215
South Jordan, UT
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Sylva, North Carolina 28779
317
mi
from 43215
Sylva, NC
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Syracuse, New York 13210
414
mi
from 43215
Syracuse, NY
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Temple, Texas 76508
1011
mi
from 43215
Temple, TX
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Tulsa, Oklahoma 74105
752
mi
from 43215
Tulsa, OK
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University Heights, Ohio 44118
131
mi
from 43215
University Heights, OH
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Warwick, Rhode Island 02888
618
mi
from 43215
Warwick, RI
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Waterloo, Iowa 50702
512
mi
from 43215
Waterloo, IA
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Waukee, Iowa 50263
579
mi
from 43215
Waukee, IA
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