At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 76 enrolled
Drug / intervention
VXA-G1.1-NN +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multicenter, Randomized, Double-blind, Placebo-controlled Single Dose, Dose-ranging Study to Evaluate the Safety, Tolerability, and Immunogenicity of Orally Administered Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females ≥ 18 Years Old and Their Breast-feeding Infants
In Brief
A Phase 1 clinical trial evaluating VXA-G1.1-NN, VXA-G2.4-NS, and 1 other intervention for Norovirus Infections. Completed, enrolled 76 participants across 5 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNorovirus Infections
CountriesSouth Africa
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartOct 2023
Primary CompletionDec 2024
First PostedNov 2025
TodayJul 2026
First PostedNov 28, 2025
Enrollment StartOct 27, 2023
Primary CompletionDec 13, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 7 months ago
Interventions
VXA-G1.1-NNbiological
Oral tablets.
VXA-G2.4-NSbiological
Oral tablets.
Placebo Tabletsbiological
Oral tablets.