Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Measles/Mumps/Rubella Vaccine & a Varicella (Chickenpox) Vaccine in Healthy Children
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis A
Intervention: Hepatitis A (Biological)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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.
Clinical Details
Official title: Study of the Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix) Administered Concomitantly With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Company, Inc. Varicella Vaccine (VARIVAX) to Healthy Children 15 m of Age
Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: "Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + MMR II and Varivax group.Immune responses for MMR II and Varivax following vaccination in both the Havrix + MMR II and Varivax group and the MMR II and Varivax followed by Havrix group. "
Secondary outcome: Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines
Detailed description:
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.
Eligibility
Minimum age: 12 Months.
Maximum age: 13 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- A male or female child 12 or 13 months of age at the time of entry into the Enrollment
Phase,
- Free of obvious health problems,
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine within 42 days preceding
the first dose of study vaccine, or planned use during the study period,
- Chronic administration 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, less than 0. 5
mg/kg/day. Inhaled, nasal and topical steroids are allowed.),
- History of or previous vaccination against 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),
- Planned administration or administration of any vaccine not foreseen by the study
protocol within the period of 42 days before and 30 days after each dose of study
vaccine(s),
- Previous vaccination against hepatitis A,
- History of hepatitis A or known exposure to hepatitis A,
- History of allergic disease/reactions or hypersensitivity likely to be exacerbated by
any component of Havrix, M-M-RII or VARIVAX, including 2-phenoxyethanol, neomycin and
gelatin,
- History of anaphylactic or anaphylactoid reactions to egg proteins,
- A history of hypersensitivity/allergic reaction to latex. (Note: The tip cap and the
rubber plunger of the Havrix needleless pre-filled syringes contain dry natural latex
rubber.),
- 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,
- Major congenital defects or serious chronic illness,
- History of any neurologic disorder (history of febrile seizures not associated with an
underlying neurological disorder does not exclude the subject),
- Acute disease, defined as the presence of a moderate or severe illness with or without
fever, 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.
Locations and Contacts
Oakland, California 94609, United States
Rolling Hills Estates, California 90274, United States
Norwich, Connecticut 06360, United States
Jacksonville, Florida 32209, United States
Marietta, Georgia 30189, United States
Woodstock, Georgia 30189, United States
Waukee, Iowa 50263, United States
Bossier City, Louisiana 71111, United States
Baltimore, Maryland 21201, United States
Henderson, Nevada 89052, United States
Las Vegas, Nevada 89104, United States
Brooklyn, New York 11201, United States
Albany, New York 12208, United States
Lumberton, North Carolina 28358, United States
Sylva, North Carolina 28779, United States
Cleveland, Ohio 44109, United States
Tulsa, Oklahoma 74104, United States
Pittsburgh, Pennsylvania 15241, United States
Sellersville, Pennsylvania 18960, United States
Norristown, Pennsylvania 19401, United States
Pittsburgh, Pennsylvania 15213, United States
Warwick, Rhode Island 02886, United States
Kingsport, Tennessee 37660, United States
Temple, Texas 76508, United States
San Antonia, Texas 78207, United States
Austin, Texas 78745, United States
Austin, Texas 78758, United States
Layton, Utah 84041, United States
South Jordan, Utah 84095, United States
Norfolk, Virginia 23510, United States
Marshfield, Wisconsin 54449, United States
Additional Information
Starting date: October 2003
Last updated: January 28, 2008
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