Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
NCT00853749
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine | |||
Official Title ICMJE | Revaccination With Pneumococcal Conjugate Vaccine - Characterization Of The Immune Response After Polysaccharide | |||
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 combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC. | |||
Detailed Description | Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
Condition ICMJE | Invasive Pneumococcal Disease | |||
Intervention ICMJE |
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Study Arms ICMJE | Single
All subjects will receive a single dose of 13vPnC Interventions:
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Publications * | Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 89 | |||
Original Estimated Enrollment ICMJE | 224 | |||
Actual Study Completion Date ICMJE | August 2010 | |||
Actual Primary Completion Date | August 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 8 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Iceland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00853749 | |||
Other Study ID Numbers ICMJE | 6096A1-3013 B1851012 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |