Clinical trials: Norovirus
Acute Gastroenteropathy Due to Norovirus
Clinical Trial of Protective Efficacy of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
The purpose of the research is to evaluate the protective efficacy, immunogenicity, and safety of quadrivalent recombinant norovirus vaccine (Pichia Pastoris) in people aged 6 weeks to 13 years.A total of 6600 infants and…
- Trial name
- NCT06524947
- Testing
- quadrivalent recombinant norovirus vaccine (Pichia pastoris)
- Where
- 3 sites in China
- Volunteers
- 6,600 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Norovirus Infection
Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
There is a need for safe, highly infectious Norovirus inocula for use in Norovirus vaccine-challenge studies to assess the efficacy of Norovirus vaccines and examine the immune response among vaccinated and unvaccinated subjects.
- Trial name
- NCT03721549
- Testing
- Norwalk GI.1 Virus
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- WCCT Global
Gastroenteritis
Efficacy and Safety of Two Doses of HIL-214 in Children
This is a randomized, placebo-controlled study that is being done to evaluate the safety and effectiveness of two doses of the HIL-214 vaccine compared to a placebo.
- Trial name
- NCT05281094
- Testing
- HIL-214
- Where
- 17 sites in United States, Colombia and 5 more
- Volunteers
- 3,084 people, healthy volunteers welcome
- Sponsor
- HilleVax
Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Ph2 Gem/Nov/Rituxan Rel/Ref MantleCell
To determine the efficacy (response rate) produced by the combination of Gemzar, Novantrone, and Rituxan in relapsed or refractory MCL
- Trial name
- NCT00656084
- Testing
- gemcitabine, mitoxantrone, rituximab
- Volunteers
- 16 people
- Sponsor
- US Oncology Research
Healthy Volunteers, Norovirus
Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
The purpose of this study is to evaluate descriptively the long-term immunogenicity of at least 1 NoV vaccine administration.
- Trial name
- NCT03039790
- Testing
- NoV Vaccine
- Where
- 11 sites in United States, Belgium
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- Takeda
Norovirus Acute Gastroenteritis
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age.
- Trial name
- NCT05992935
- Testing
- mRNA-1403, mRNA-1405
- Where
- 16 sites in United States, Australia
- Volunteers
- 1,407 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Norovirus Infections, Norwalk Gastroenteritis
Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)
Phase II clinical study will explore dose and safety, immunogenicity in 4 age groups, including 18-59 years old group, 6-17 years old group, 3-5 years old group, 6-35 months old group, with a total of 1716 subjects.
- Trial name
- NCT04941261
- Testing
- middle-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine, high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine
- Where
- China
- Volunteers
- 1,716 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
Norovirus Infections
Norovirus Challenge Study
This is a Phase 2b randomized, double-blind, placebo-controlled vaccination and challenge study to assess the protective efficacy of the Vaxart Norovirus vaccine (VXA-G1.1-NN).
- Trial name
- G1-1 Challenge (NCT05212168)
- Testing
- VXA-G1.1-NN, Norovirus GI.1 Norwalk Virus Inoculum
- Where
- United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus
Participants in this study will be given either CDI-988 or placebo orally before receiving a norovirus challenge virus and continuing for 5 days. Participants will not know whether they are getting placebo or CDI-988.
- Trial name
- NCT07198139
- Testing
- CDI-988, Snow Mountain Virus
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cocrystal Pharma, Inc.
Norovirus Infection
Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines
VXA-NVV-103 is a phase 1B Randomized, Double-Blind, Placebo-Controlled, Multi-Center Safety and Immunogenicity Study of Adenoviral-vector Based Oral Norovirus Vaccines Expressing GI.1 or GII.4 VP1 with Monovalent or Bivalent…
- Trial name
- VXA-NVV-103 (NCT03897309)
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Vaxart
Prevention From Norovirus Infection
Norovirus Bivalent-Vaccine Efficacy Study
The purpose of this study is to determine whether the norovirus vaccine is effective in preventing acute gastroenteritis due to the experimental human Norovirus GII.4 challenge dose.
- Trial name
- NCT01609257
- Testing
- Norovirus Bivalent Vaccine, Saline Comparator
- Where
- 5 sites in United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastroenteritis
Safety and Immunogenicity of HIL-214 in Healthy Japanese Infants
This is a phase 1, randomized, double-blind multi-center, placebo-controlled trial in Japan to evaluate the safety and immunogenicity of HIL-214 in healthy infants 5 months of age (-14/+14 days) at first trial vaccine…
- Trial name
- NCT06007781
- Testing
- HIL-214
- Where
- 4 sites in Japan
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- HilleVax
Norovirus Infections, Norovirus Gastroenteritis
A Study to Evaluate INT101 in Healthy Adults for the Prevention of Norovirus Gastroenteritis
This study is being conducted to evaluate the safety and immunogenicity of INT101, an investigational vaccine intended to prevent norovirus gastroenteritis, in healthy adults.
- Trial name
- INT-101 (NCT07818629)
- Testing
- INT101 Low Dose, INT101 High Dose
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- InThera Inc. Korea
Fibrostenotic Crohn's Disease
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Many patients with Crohn's disease (CD) develop fibrotic narrowing (strictures) in their bowel, causing obstructive symptoms such as abdominal pain, cramping, or vomiting after meals.
- Trial name
- NCT07683325
- Testing
- Ontunisertib
- Where
- 11 sites in United States, Serbia and 1 more
- Volunteers
- 320 people
- Sponsor
- Agomab Spain S.L.U.
Acute Gastroenteritis
A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
The ARIES Norovirus Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool specimens obtained from symptomatic patients.
- Trial name
- NCT02092259
- Where
- 5 sites in United States
- Volunteers
- 500 people
- Sponsor
- Luminex Corporation
Norovirus Gastroenteritis
Phase 1 Placebo-controlled, Randomized Trial of an Adenoviral-vector Based Norovirus Vaccine
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Norovirus Vaccine (VXA-G1.1-NN) Expressing GI.1 VP1 and dsRNA Adjuvant…
- Trial name
- NCT02868073
- Testing
- VXA-G1.1-NN (high dose) Oral Vaccine Tablet, VXA-G1.1-NN (low dose) Oral Vaccine Tablet
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Vaxart
Acute Gastroenteritis, Norovirus Acute Gastroenteritis
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE)…
- Trial name
- Nova 301 (NCT06592794)
- Testing
- mRNA-1403
- Where
- 283 sites in United States, Australia and 5 more
- Volunteers
- 37,864 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Norovirus Infections
A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
This study is designed to evaluate the safety and immunogenicity of two monovalent Norovirus (NoV) oral tableted vaccine candidates, VXA-G1.1-NN and VXA-GII.4-NS co-administered (bivalent delivery) against a matching placebo arm.
- Trial name
- NCT05626803
- Testing
- 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
- Where
- 3 sites in United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus Prevention
Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
The purpose of this study is to evaluate the safety of the norovirus bivalent virus-like particle (VLP) vaccine for further development by assessing the rates of serious adverse events (SAEs), unsolicited adverse events (AEs)…
- Trial name
- NCT02142504
- Testing
- Norovirus Bivalent VLP Vaccine
- Where
- 10 sites in United States
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- Takeda
Gastroenteritis
Bivalent Norovirus Vaccine Study
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls.
- Trial name
- NCT01168401
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine, Saline
- Where
- 3 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Takeda