Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age
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Purpose
click on markers to display additional informationThis 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
status: completed conditions: Hepatitis A interventions: Hepatitis A phase: Phase 3 study type: Interventional study design: Prevention, Randomized, Open Label, Parallel Assignment, Safety Study official title: A Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix) Administered Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine (Prevnar) in Healthy Children 15 Mths of Age -
Further study details (as provided by GlaxoSmithKline)
primary outcome measures:
- Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group.
secondary outcome measures:
- Immune response for Prevnar following vaccination in both the Havrix + Prevnar group and the Prevnar followed by Havrix group.
- Immune response for Havrix following the first dose of Havrix in all groups. The other secondary outcome measure is safety of the study vaccines.
enrollment: 480
study start date: September 2003
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.
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Eligibility
ages eligible for study: 12 Months to 13 Months genders eligible for study: 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,
- Subjects must have previously received three doses of Prevnar in his/her first year of life.
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.),
- 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.
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Contacts and locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197002
Locations
United States , Colorado - GSK Investigational Site
facility: Centennial, Colorado, United States, 80112
United States , Kentucky - GSK Investigational Site
facility: Louisville, Kentucky, United States, 40202
United States , Kentucky - GSK Investigational Site
facility: Bardstown, Kentucky, United States, 40004
United States , Massachusetts - GSK Investigational Site
facility: Boston, Massachusetts, United States, 02118
United States , Massachusetts - GSK Investigational Site
facility: Boston, Massachusetts, United States, 02115
United States , Michigan - GSK Investigational Site
facility: Kalamazoo, Michigan, United States, 49008
United States , Nevada - GSK Investigational Site
facility: North Las Vegas, Nevada, United States, 89025
United States , New York - GSK Investigational Site
facility: Stony Brook, New York, United States, 11794
United States , North Carolina - GSK Investigational Site
facility: Chapel Hill, North Carolina, United States, 27514
United States , Ohio - GSK Investigational Site
facility: University Heights, Ohio, United States, 44118
United States , Pennsylvania - GSK Investigational Site
facility: Pittsburgh, Pennsylvania, United States, 15241
United States , Texas - GSK Investigational Site
facility: San Antonio, Texas, United States, 78205-2489
United States , Utah - GSK Investigational Site
facility: Salt Lake City, Utah, United States, 84109
United States , Washington - GSK Investigational Site
facility: Vancouver, Washington, United States, 98664
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Sponsors and collaborators
GlaxoSmithKline
investigators: GSK Clinical Trials, Study Director, GlaxoSmithKline
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More information
first received: September 13, 2005 last updated: October 9, 2008 ClinicalTrials.gov Identifier: NCT00197002 health authority: United States: Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 25, 2009 Link to the current ClinicalTrials.gov record.
