drugset / Trial / NCT00213265

Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants

NCT00213265

Phase 3 Completed 81 enrolled The Hospital for Sick Children
RandomizedParallel-groupOpen-labelTreatment

Summary

We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and effective in protecting children who have had a solid organ transplantation and healthy children from pneumococcal infections. We expect that two or more doses of Prevnar™ will result in similar antibody responses among transplant recipients compared with healthy control subjects, and that children who have undergone solid organ transplant will have a similar number of serious vaccine-related adverse events within 7 days after Prevnar™ as the healthy patients.

Timeline

Start
2002-07
Primary completion
2017-02
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Prevnar 13 Vaccine 0.5 ml