drugset / Trial / NCT07254728
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
RandomizedParallel-groupDouble-blindPrevention
Summary
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity of oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and its association with the immunogenicity response in breastmilk.
Timeline
- Start
- 2023-10-27
- Primary completion
- 2024-12-13
- Completion
- 2024-12-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VXA-G1.1-NN | Vaccine | — | Oral |
| Subject | VXA-G2.4-NS | Vaccine | — | Oral |