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

NCT07254728 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-04-15

Study results available
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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.

Conditions

  • Norovirus Infections

Interventions

BIOLOGICAL

VXA-G1.1-NN

Oral tablets.

BIOLOGICAL

VXA-G2.4-NS

Oral tablets.

BIOLOGICAL

Placebo Tablets

Oral tablets.

Sponsors & Collaborators

  • Vaxart

    lead INDUSTRY

Principal Investigators

  • Medical Director · Vaxart, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2024-12-13
Completion
2024-12-13
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07254728 on ClinicalTrials.gov