drugset / Trial / NCT06101173
A Study to Evaluate the Safety and Immunogenicity of Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) in Healthy Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a randomized, observer-blind, positive-controlled study. There will be 3 treatment groups, in each treatment group, participants will be randomly assigned to receive either investigational vaccine (Low-adjuvant dose VLP-Polio, Medium dose VLP-Polio, or High dose VLP-Polio that are defined as Dose A, Dose M, and Dose H, respectively) or control vaccine in a ratio of 3:1 in each group. Distribution of participant's gender should be balanced in each group.
Timeline
- Start
- 2024-01-15
- Primary completion
- 2024-03-15
- Completion
- 2024-09-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inactivated poliomyelitis vaccine | Vaccine | 0.5 ml | Intramuscular |
| Subject | VLP-Polio | Vaccine | 0.5 ml | Intramuscular |