drugset / Trial / NCT01525004
Standard Dose Versus High-Dose Inactivated Flu Vaccine in Pediatric Solid Organ Transplant Patients
Phase 1
Completed
38 enrolled
Vanderbilt University
MCM Vaccines B.V. · collabUniversity of Pittsburgh · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a phase I trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (SOT).
Timeline
- Start
- 2011-09
- Primary completion
- 2012-06
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Influenza Virus Vaccine | Vaccine | 60 ug | Intramuscular |
| Subject | Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Standard dose trivalent inactivated influenza vaccine | Vaccine | 15 ug | Intramuscular |
| Comparator | Standard dose trivalent inactivated influenza vaccine | Vaccine | 0.5 ml | Intramuscular |