Bivalent GII.4/GI.1 vaccine / Vaxart - LARVOL DELTA

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: Vaxart | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Vaxart Announces Clinical Trial Initiation of Norovirus Oral Pill Vaccine Candidate (GlobeNewswire) - "Vaxart, Inc...announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs....'With no currently approved vaccines against norovirus, we are committed to advancing what we believe is the most promising norovirus vaccine candidate in clinical development and look forward to reviewing the topline data that is expected as early as mid-2025'....If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025, followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026."

New P2 trial • New P3 trial • P1 data • Trial status • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Vaxart | Trial completion date: Apr 2024 ➔ Jul 2024

Trial completion date • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Vaxart | Trial completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Active, not recruiting | Sponsor: Vaxart | Trial primary completion date: Jun 2023 ➔ Oct 2023

Trial primary completion date • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=125 | Active, not recruiting | Sponsor: Vaxart | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=135 | Recruiting | Sponsor: Vaxart | N=623 ➔ 135 | Initiation date: Dec 2022 ➔ Feb 2022

Enrollment change • Trial initiation date • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=623 | Recruiting | Sponsor: Vaxart | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers (clinicaltrials.gov) - P2 | N=623 | Not yet recruiting | Sponsor: Vaxart

New P2 trial • Infectious Disease