Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT00197002
Eligibility 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
13 Months
Study:
NCT00197002
Study Brief:
Protocol Section:
NCT00197002