Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipie⦠(NCT01527591) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Pneumococcal Conjugate Vaccine 13 (Prevnar13Ā®) in Children Who Are Solid Organ Transplant Recipients (SOT)
United States17 participantsStarted 2012-02-01
Plain-language summary
The purpose of this study is to determine the safety and long-term immunogenicity of the 13-Valent Pneumococcal Conjugate vaccine in children who are solid organ transplant recipients.
Who can participate
Age range12 Months ā 59 Months
SexALL
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Inclusion Criteria:
* Are 12 to 59 months of age.
* Have received a solid organ transplantation requiring ongoing immunosuppression.
* Have been receiving immunosuppressive agents for at least 3 months. Non-steroidal anti-inflammatory agents, G-CSF, erythropoietin and inhaled corticosteroids are not considered immunosuppressive agents for the purposes of this study.
* Expect to be able to complete the study injection and follow-up.
* Have parent or guardian's consent.
* Have received at least 3 doses of an approved PCV7 and/or PCV13 vaccine series.
Exclusion Criteria:
* Have received any inactivated vaccine within 4 weeks, or any live vaccine within 6 weeks of entering the study.
* Have had an allergic reaction or a serious side effect after receipt of any previous immunization to pneumococcal vaccines, or to other routine childhood immunizations.
* Have any other condition that would make receiving study vaccine inadvisable.
* Have other diseases of the immune system.
* Have any other disease or previous surgery that would interfere with study treatment.
* Are likely to have bleeding disorders.
What they're measuring
1
To measure antibody concentrations by EIA and opsonophagocytosis assay (OPA)
Timeframe: Measured at different time points until 240 weeks post PCV 13 booster dose