drugset / Trial / NCT04033068
Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001)
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years
Timeline
- Start
- 2019-08-02
- Primary completion
- 2020-01-30
- Completion
- 2020-06-10
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
registry analysis (superiority test); Group A: V187 (High Dose) - V187 (High Dose) vs Group B: V187 (Low Dose) - V187 (Low Dose) vs Group C: V187 (High Dose) - Placebo vs Group D: Placebo - Placebo; p = 0.2003; Fisher-Freeman-Halton Test NCT04033068 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MV-ZIKA-RSP | Vaccine | 25000 unknown | — |
| Subject | MV-ZIKA-RSP | Vaccine | 100000 unknown | — |