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
974
mi
from
Pittsburgh, PA
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Albany, New York 12206
1308
mi
from
Albany, NY
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Austin, Texas 78705
515
mi
from
Austin, TX
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Baltimore, Maryland 21201
1148
mi
from
Baltimore, MD
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1000 GSK Drive
Beaver Falls, Pennsylvania 15010
962
mi
from
Beaver Falls, PA
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Bossier City, Louisiana 71111
429
mi
from
Bossier City, LA
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Bristol, Tennessee 37620
863
mi
from
Bristol, TN
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Brooklyn, New York 11215
1288
mi
from
Brooklyn, NY
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Cabot, Arkansas 72023
?
mi
from
Cabot, AR
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Cleveland, Ohio 44195
898
mi
from
Cleveland, OH
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Henderson, Nevada 89052
957
mi
from
Henderson, NV
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Huntington Beach, California 92647
1162
mi
from
Huntington Beach, CA
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Jacksonville, Florida 32207
1058
mi
from
Jacksonville, FL
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Jonesboro, Arkansas 72401
415
mi
from
Jonesboro, AR
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Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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Las Vegas, Nevada 89102
963
mi
from
Las Vegas, NV
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Layton, Utah 84041
788
mi
from
Layton, UT
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Lexington, Kentucky 40504
723
mi
from
Lexington, KY
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Lumberton, North Carolina 28358
?
mi
from
Lumberton, NC
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Marietta, Georgia 30060
788
mi
from
Marietta, GA
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Marshfield, Wisconsin 54449
621
mi
from
Marshfield, WI
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Norfolk, Virginia 23502
1186
mi
from
Norfolk, VA
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Norristown, Pennsylvania 19401
1216
mi
from
Norristown, PA
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North Little Rock, Arkansas 72117
371
mi
from
North Little Rock, AR
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Norwich, Connecticut 06360
1389
mi
from
Norwich, CT
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Oakland, California 94611
1327
mi
from
Oakland, CA
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Rochester, New York 14642
1121
mi
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Rochester, NY
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Rolling Hills Estates, California 90274
1180
mi
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Rolling Hills Estates, CA
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5 Crescent Drive
Rydal, Pennsylvania 19046
1224
mi
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Rydal, PA
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San Antonio, Texas 78258
561
mi
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San Antonio, TX
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Sellersville, Pennsylvania 18960
1218
mi
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Sellersville, PA
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South Jordan, Utah 84095
779
mi
from
South Jordan, UT
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Sylva, North Carolina 28779
825
mi
from
Sylva, NC
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Syracuse, New York 13210
1194
mi
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Syracuse, NY
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Temple, Texas 76508
461
mi
from
Temple, TX
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Tulsa, Oklahoma 74105
152
mi
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Tulsa, OK
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University Heights, Ohio 44118
902
mi
from
University Heights, OH
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Warwick, Rhode Island 02888
1423
mi
from
Warwick, RI
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Waterloo, Iowa 50702
436
mi
from
Waterloo, IA
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Waukee, Iowa 50263
338
mi
from
Waukee, IA
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