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

NCT07254728 ↗

Phase 1 Completed 76 enrolled Vaxart
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

EvaluationDrugModalityDoseRoute
Subject VXA-G1.1-NN Vaccine — Oral
Subject VXA-G2.4-NS Vaccine — Oral