Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Condition: Pneumococcal Conjugate Vaccine
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 13-valent Pneumococcal Conjugate Vaccine
Intervention description: single injection, single dose, single site, 0.5 mL per dose.; single injection, single dose, single site, 0.5 mL per dose.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 8 Years
Maximum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Single site; single dose; Participated in Wyeth D118-P8

Summary:

      The purpose of this study is to assess the "late" immune response to further doses of
      pneumococcal conjugate vaccine more than 10 years after primary immunization with Prevnar
      (7vPnC) in infancy, as compared with individuals who did not receive Prevnar in infancy (the
      Prevnar naive cohort which received MnCC). The study will take place at a single study
      center. Study participants must have participated previously in a specific Wyeth Prevnar
      study (Study D118-P8) and must still be enrolled in the Northern California Kaiser Permanente
      (NCKP) health plan.
    

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.