Status:
COMPLETED
Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
Lead Sponsor:
Pfizer
Conditions:
Pneumococcal Conjugate Vaccine
Eligibility:
All Genders
8-16 years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00824850
Start Date
January 1 2010
End Date
September 1 2010
Last Update
November 11 2011
Active Locations (2)
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1
Pfizer Investigational Site
Hayward, California, United States, 94545
2
Pfizer Investigational Site
San Jose, California, United States, 95119