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:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-24 @ 5:10 PM
NCT ID:
NCT00824850
Eligibility Criteria:
Inclusion Criteria:
* Fully vaccinated per-protocol (4 doses of vaccine given at 2, 4, 6, and 12-15 months of age) subjects enrolled in the Prevnar arm of Study D118-P8, OR
* Fully vaccinated per-protocol subjects from the control arm of the same study that did not receive Prevnar after the close of Study D118-P8, or at any time following the study, AND
* Still enrolled in NCKP health plan.
* Subjects included in either group above must be in good health as determined by medical history, physical examination, and clinical judgment.
Exclusion Criteria:
* Previous receipt of pneumococcal polysaccharide vaccine.
* History of documented recurrent pneumococcal otitis media or any occurence of pneumonia within past 12 months
* History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
* Known or suspected disease or dysfunction of the immune system, including:
* HIV infection
* Malignancy
* Receipt of immunosuppressive therapy
* Sickle cell hemoglobinopathy
* Concomitant vaccination during the study period.
* Known hypersensitivity to any component of Prevnar.
* Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.
* Receipt of immune globulin within the past 3 months.
* Positive pregnancy test for menarchal female subjects.
* Females who are breastfeeding.
* For control subjects, previous receipt of Prevnar at any time.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
16 Years
Study:
NCT00824850
Study Brief:
Protocol Section:
NCT00824850