Study Evaluating Prevnar Infant Long-term Immune Response Versus Prevnar Naive Cohort
NCT ID: NCT00824850
Last Updated: 2011-11-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2010-01-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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1
Subjects received Prevnar in study D118-P8
13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
2
Subjects received MnCC in study D118-P8
13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
Interventions
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13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
13-valent Pneumococcal Conjugate Vaccine
single injection, single dose, single site, 0.5 mL per dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
8 Years
16 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Hayward, California, United States
Pfizer Investigational Site
San Jose, California, United States
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1851014
Identifier Type: -
Identifier Source: secondary_id
6096A1-3016
Identifier Type: -
Identifier Source: org_study_id