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

Completed · Phase 3

Conditions studied: Hepatitis A

In brief

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.

Key facts

Study ID

NCT00197015

Run by

GlaxoSmithKline

People needed

1474

Starts

2003-10-06

Expected to finish

2009-06-09

Last updated by the study team

2018-07-31

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Cabot, Arkansas, United States
• GSK Investigational Site — Jonesboro, Arkansas, United States
• GSK Investigational Site — North Little Rock, Arkansas, United States
• GSK Investigational Site — Huntington Beach, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Rolling Hills Estates, California, United States
• GSK Investigational Site — Norwich, Connecticut, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Waterloo, Iowa, United States
• GSK Investigational Site — Waukee, Iowa, United States
• GSK Investigational Site — Lexington, Kentucky, United States
• GSK Investigational Site — Bossier City, Louisiana, United States
• GSK Investigational Site — Baltimore, Maryland, United States
• GSK Investigational Site — Henderson, Nevada, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — Albany, New York, United States
• GSK Investigational Site — Brooklyn, New York, United States
• GSK Investigational Site — Rochester, New York, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Lumberton, North Carolina, United States
• GSK Investigational Site — Sylva, North Carolina, United States
• GSK Investigational Site — Cleveland, Ohio, United States
• GSK Investigational Site — University Heights, Ohio, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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