Clinical Trial

A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants

Completed Phase 1
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-19.
Trial Details
NCT Number NCT07254728
Lead Sponsor Vaxart
Conditions Norovirus Infections
Enrollment 76 participants
Start Date 2023-10-27
Primary Completion 2024-12-13 (estimated)
Study Completion 2024-12-13 (estimated)
Updated on ClinicalTrials.gov 2026-04-15