Status:
ACTIVE_NOT_RECRUITING
Pneumococcal Conjugate Vaccine 13 (Prevnar13®) in Children Who Are Solid Organ Transplant Recipients (SOT)
Lead Sponsor:
University of California, Los Angeles
Conditions:
Infection in Solid Organ Transplant Recipients
Eligibility:
All Genders
12-59 years
Phase:
NA
Brief 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.
Detailed Description
The purpose of this study is to determine if a booster dose of 13-valent pneumococcal conjugate vaccine (PCV13) is safe and results in a measurable and durable immunologic response against pneumococca...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2025
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01527591
Start Date
February 1 2012
End Date
December 30 2025
Last Update
April 2 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA
Los Angeles, California, United States, 90095-1752