drugset / Trial / NCT05447377
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
Timeline
- Start
- 2022-09-16
- Primary completion
- 2024-01-30
- Completion
- 2024-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SII Yellow Fever Vaccine | Vaccine | 0.5 ml | — |
| Subject | SII Yellow Fever Vaccine | Vaccine | 1000 iu | — |
| Comparator | Yellow Fever Vaccine | Vaccine | 0.5 ml | — |
| Comparator | Yellow Fever Vaccine | Vaccine | 1000 iu | — |