Status:
COMPLETED
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Pfizer
Conditions:
Invasive Pneumococcal Disease
Eligibility:
All Genders
5-7 years
Phase:
PHASE3
Brief Summary
The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a...
Detailed Description
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
Eligibility Criteria
Inclusion
- Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
- Subjects must be in good health as determined by medical history, physical examination and clinical judgment.
Exclusion
- Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
- History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
- Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
- Receipt of immune-globulin within the past 3 months.
- Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
Key Trial Info
Start Date :
May 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2009
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00853749
Start Date
May 5 2009
End Date
December 16 2009
Last Update
November 11 2021
Active Locations (2)
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1
Landspitali University Hospital
Hringbraut, Reykjavik, Iceland, 101
2
Midstod Heilsuverndar barna
Reykjavik, Iceland, 109