| September 13, 2005 |
| October 9, 2008 |
| September 2003 |
| |
| Immune response for Havrix following the second dose of Havrix in both the Havrix group and the Havrix + Prevnar group. |
| Same as current |
| Complete list of historical versions of study NCT00197002 on ClinicalTrials.gov Archive Site |
- 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.
|
| Same as current |
| |
| Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age |
| 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 |
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 |
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. |
| Phase III |
| Interventional |
| Prevention, Randomized, Open Label, Parallel Assignment, Safety Study |
| Hepatitis A |
| Biological: Hepatitis A |
| |
| |
| |
| Completed |
| 480 |
|
|
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.
|
| Both |
| 12 Months to 13 Months |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00197002 |
| Study Director, GSK |
| 208109/220 |
| GlaxoSmithKline |
|
| Study Director: |
GSK Clinical Trials |
GlaxoSmithKline |
|
|
| GlaxoSmithKline |
| October 2008 |