Clinical trial NCT00824850: Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Official title: Characterization of the Prevnar Infant Long-term Immune Response vs a Prevnar Naive Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumococcal Conjugate Vaccine
Keywords: Single site
single dose
Participated in Wyeth D118-P8
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-19
Enrollment: 75
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Primary outcomes:
measure: Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
timeFrame: Day 28 (Visit 5)
measure: Percentage of Participants Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
timeFrame: Day 7 (Visit 4)
measure: Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
timeFrame: Day 28 (Visit 5)
measure: Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
timeFrame: Day 7 (Visit 4)
measure: Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)
timeFrame: Day 28 (Visit 5)
measure: Percentage of Participants Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)
timeFrame: Day 7 (Visit 4)
Secondary outcomes:
measure: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
timeFrame: Baseline (Visit 1), Day 28 (Visit 5)
measure: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
timeFrame: Baseline (Visit 1), Day 28 (Visit 5)
measure: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
timeFrame: Baseline (Visit 1), Day 7 (Visit 4)
measure: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
timeFrame: Baseline (Visit 1), Day 7 (Visit 4)
measure: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
timeFrame: Baseline (Visit 1), Day 28 (Visit 5)
measure: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5
timeFrame: Baseline (Visit 1), Day 28 (Visit 5)
measure: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
timeFrame: Baseline (Visit 1), Day 7 (Visit 4)
measure: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4
timeFrame: Baseline (Visit 1), Day 7 (Visit 4)
measure: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
timeFrame: Day 28 (Visit 5)
measure: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
timeFrame: Day 7 (Visit 4)
measure: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)
timeFrame: Day 28 (Visit 5)
measure: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)
timeFrame: Day 7 (Visit 4)
Other outcomes:
measure: Percentage of Participants Reporting Pre-specified Local Reactions Within 4 Days After Vaccination
timeFrame: Baseline up to 4 days after vaccination on Day 1
measure: Percentage of Participants Reporting Pre-specified Systemic Events Within 4 Days After Vaccination
timeFrame: Baseline up to 4 days after vaccination on Day 1
Locations:
city: Hayward
country: United States
facility: Pfizer Investigational Site
state: California
city: San Jose
country: United States
facility: Pfizer Investigational Site
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Klein NP, Ensor K, Jouve S, Northington R, Moscariello M, McGovern PC. Long-term immune responses to pneumococcal conjugate vaccines in children previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2013 Sep;32(9):990-7. doi: 10.1097/INF.0b013e3182959f34.