Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort (PILOT)

Pfizer

Status and phase

Completed

Phase 2

Conditions

Pneumococcal Conjugate Vaccine

Treatments

Biological: 13-valent Pneumococcal Conjugate Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00824850

B1851014

6096A1-3016

Details and patient eligibility

About

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.

Enrollment

75 patients

Sex

All

Ages

8 to 16 years old

Volunteers

Accepts Healthy Volunteers

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.