Status:
COMPLETED
Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis A
Eligibility:
All Genders
12-13 years
Phase:
PHASE3
Brief Summary
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 m...
Detailed Description
An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 11 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2006
Estimated Enrollment :
521 Patients enrolled
Trial Details
Trial ID
NCT00197002
Start Date
September 11 2003
End Date
January 16 2006
Last Update
August 6 2018
Active Locations (18)
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1
GSK Investigational Site
Centennial, Colorado, United States, 80112
2
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
3
GSK Investigational Site
Louisville, Kentucky, United States, 40202
4
GSK Investigational Site
Boston, Massachusetts, United States, 02115