14 completed, 2 recruiting, 1 active not recruiting, 1 terminated. 11 Phase 1, 5 Phase 2, 2 Not applicable, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 10, Recruiting 1 |
| Phase 2 | 5 | Completed 4, Unknown 1 |
| Not applicable | 2 | Active not recruiting 1, Terminated 1 |
| Phase 3 | 2 | Completed 2 |
Follow Caliciviridae Infections: new trials by email Literature Review of Caliciviridae Infections trials Research Report on Caliciviridae Infections
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis INT101 Low Dose, INT101 High Dose, INT101 Placebo (0.25 mL) - Norovirus Infections, Norovirus Gastroenteritis | Phase 1 | Recruiting | InThera Inc. Korea | 30 | 2026-08-10 | 2026-09-14 |
| Norovirus Prevalence and Fecal Microbiome Characterization Through Metagenomic and Metatranscriptomic Analyses Characterization the fecal microbiome composition in travelers - Microbiome, Metagenomic Next Generation Sequencing | Not applicable | Active not recruiting | IRCCS Sacro Cuore Don Calabria di Negrar | 100 | 2026-07-28 | 2026-10-08 |
| Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective Dengue, Chikungunya | Recruiting | Institut Pasteur du Cambodge | 10000 | 2025-12-18 | 2026-01-22 | |
| A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old VXA-G1.1-NN, VXA-G2.4-NS, VXA G1.1 NN-T - Norovirus Infections | Phase 1 | Completed | Vaxart | 60 | 2025-03-03 | 2026-07-27 |
| A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants VXA-G1.1-NN, VXA-G2.4-NS, Placebo Tablets - Norovirus Infections | Phase 1 | Completed | Vaxart | 76 | 2023-10-27 | 2026-04-15 |
| Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha) Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha), placebo - Norovirus Infections, Norwalk Gastroenteritis | Phase 3 | Completed | National Vaccine and Serum Institute, China | 8000 | 2023-06-30 | 2026-01-16 |
| A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers Open label Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 high dose vaccine 2×10 to the power 11 IU/dose, Bivalent GII.4/GI.1 medium dose vaccine 1×10 to the power 11 IU/dose - Norovirus Infections | Phase 2 | Completed | Vaxart | 135 | 2023-01-26 | 2025-04-15 |
| A Phase 1, Open-label, Safety and Immunogenicity Study of an Oral Multi-dose Administration Regimen With an Adenoviral-vector Based Tablet Norovirus Vaccine (VXA-G1.1-NN) Administered to Healthy Adult Volunteers VXA-G1.1-NN - Norovirus Infections | Phase 1 | Completed | Vaxart | 8 | 2022-01-24 | 2024-06-21 |
| Norovirus Challenge Study VXA-G1.1-NN, Placebo Tablets, Norovirus GI.1 Norwalk Virus Inoculum - Norovirus Infections | Phase 1 / Phase 2 | Completed | Vaxart | 165 | 2021-12-27 | 2025-11-05 |
| Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha) middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, placebo - Norovirus Infections, Norwalk Gastroenteritis | Phase 2 | Unknown | National Vaccine and Serum Institute, China | 1716 | 2021-06-30 | 2022-10-28 |
| Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines VXA-G1.1-NN - Norovirus Infections | Phase 1 / Phase 2 | Completed | Vaxart | 30 | 2021-04-30 | 2024-05-22 |
| Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine VXA-GI.1.NN, Placebo Tablet - Norovirus Infections | Phase 1 | Completed | Vaxart | 66 | 2021-04-26 | 2023-02-13 |
| A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） - Norwalk Gastroenteritis, Norovirus Infections | Phase 1 | Completed | National Vaccine and Serum Institute, China | 510 | 2019-11-28 | 2021-04-22 |
| Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines VXA-G1.1-NN, VXA-G2.4-NS, Placebo Tablets - Norovirus Infection | Phase 1 | Completed | Vaxart | 86 | 2019-03-20 | 2022-09-21 |
| Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model Norwalk GI.1 Virus - Norovirus Infection | Phase 1 | Completed | WCCT Global | 16 | 2018-10-03 | 2020-01-22 |
| Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic Gastroenteritis, Rota Virus Gastroenteritis | Completed | Region Zealand | 600 | 2017-01-01 | 2024-01-18 | |
| Human Breastmilk in Young Children With Norovirus Infection of the Gut Donor Breastmilk - Norovirus Infections | Not applicable | Terminated | Children's Hospital Medical Center, Cincinnati | 4 | 2014-10-01 | 2020-08-20 |
| Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1) Norovirus challenge pool (GII.4, CIN-1) - Norovirus Infections | Phase 1 | Completed | Children's Hospital Medical Center, Cincinnati | 60 | 2011-08-01 | 2014-05-07 |
| Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children Alinia (nitazoxanide) - Rotavirus Infection, Adenoviridae Infection | Phase 2 / Phase 3 | Completed | Romark Laboratories L.C. | 50 | 2005-02-01 | 2012-05-31 |
Adenoviridae Infections (2) · Communicable Diseases (2) · Rotavirus Infections (2) · Arenaviridae Infections (1) · Brucellosis (1) · Bunyaviridae Infections (1) · COVID-19 (1) · Chickenpox (1) · Chikungunya Fever (1) · Chlamydia Infections (1) · Dehydration (1) · Dengue (1) · Diarrhea (1) · Elephantiasis, Filarial (1)
Infections (19) · RNA Virus Infections (19) · Virus Diseases (19) · DNA Virus Infections (2) · Digestive System Diseases (2) · Disease Attributes (2) · Gastrointestinal Diseases (2) · Pathologic Processes (2) · Pathological Conditions, Signs and Symptoms (2) · Reoviridae Infections (2) · Respiratory Tract Diseases (2) · Respiratory Tract Infections (2) · Adenophorea Infections (1) · Alphavirus Infections (1) · Animal Diseases (1)
Saline Solution (1) · Vaccines (1) · nitazoxanide (1)
Vaxart (8) · National Vaccine and Serum Institute, China (3) · Children's Hospital Medical Center, Cincinnati (2) · IRCCS Sacro Cuore Don Calabria di Negrar (1) · InThera Inc. Korea (1) · Institut Pasteur du Cambodge (1) · Region Zealand (1) · Romark Laboratories L.C. (1) · WCCT Global (1)
United States (10) · China (3) · Cambodia (1) · Denmark (1) · Italy (1) · South Africa (1) · South Korea (1)
James Cummings, MD (3) · Claude Flamand, Ph.D. (1) · David Liebowitz, MD, PhD (1) · Helen Paguntalan, MD (1) · Javier El-Bietar, MD (1) · Joonsup Yeom, MD, PhD (1) · Maren Rytter, PhD (1) · Mary Beth Manning, MD (1) · Mona Abu-Zekry, MD (1)