drugset / Trial / NCT06485258
CDC-9 Inactivated Rotavirus Vaccine (IRV) Intramuscular (IM) Phase 1 Clinical Trial in Healthy Adults
Phase 1
Completed
50 enrolled
Centers for Disease Control and Prevention
Bill and Melinda Gates Foundation · collabChildren's Hospital Medical Center, Cincinnati · collabEmory-Children's Center · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a study of CDC-9 inactivated rotavirus vaccine (IRV) for intramuscular administration (IM) in healthy adults aged 18 to 45 years at two dose levels in a 3-dose series. The purpose is to determine if it is safe and if the recipient's immune system responds to the vaccine.
Timeline
- Start
- 2024-08-06
- Primary completion
- 2026-02-04
- Completion
- 2026-02-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CDC-9 Inactivated Rotavirus Vaccine | Vaccine | 3.75 ug | Intramuscular |
| Subject | CDC-9 Inactivated Rotavirus Vaccine | Vaccine | 7.5 ug | Intramuscular |