- 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
- 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.
- 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
- 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.