Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age

Completed · Phase 3

Conditions studied: Hepatitis A

In brief

This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.

Key facts

Study ID

NCT00197002

Run by

GlaxoSmithKline

People needed

521

Starts

2003-09-11

Expected to finish

2006-01-16

Last updated by the study team

2018-08-06

Who can join

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

You may qualify if…

• 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,
• Subjects must have previously received three doses of Prevnar in his/her first year of life.

You may not qualify if…

• 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.),
• Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study,
• 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,
• 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 Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid),
• 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.

Where it is running

• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Bardstown, Kentucky, United States
• GSK Investigational Site — Louisville, Kentucky, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Kalamazoo, Michigan, United States
• GSK Investigational Site — Omaha, Nebraska, United States
• GSK Investigational Site — Las Vegas, Nevada, United States
• GSK Investigational Site — North Las Vegas, Nevada, United States
• GSK Investigational Site — Stony Brook, New York, United States
• GSK Investigational Site — Chapel Hill, North Carolina, United States
• GSK Investigational Site — University Heights, Ohio, United States
• GSK Investigational Site — Pittsburgh, Pennsylvania, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — San Antonio, Texas, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — Salt Lake City, Utah, United States
• GSK Investigational Site — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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