Clinical trials: Gastroenteritis Norovirus
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
Healthy
Infectivity of Norovirus in Shellfish Treated With High Hydrostatic Pressure Processing-Human Challenge Study
Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States.
- Trial name
- Shellfish (NCT00674336)
- Testing
- High Hydrostatic Pressure Processing
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Emory University
Gastroenteritis Norovirus
Phase I Study to Determine the Optimal Human Challenge Dose for a Norovirus GII.4 Challenge Stock (CIN-1)
This is phase I, double blind, placebo-controlled safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to healthy adults 18-49 years of age.
- Trial name
- NCT02337842
- Testing
- Norovirus GII.4 Challenge Pool CIN-1
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
Gastroenteritis Norovirus
New Challenge Pool of Norwalk Virus Inoculum
The main objective of this study is to see the number of volunteers that get sick from a Norwalk virus (NV) inoculation with typical symptoms of nausea, vomiting, and diarrhea.
- Trial name
- NCT00138476
- Testing
- Norwalk Virus
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 Gastroenteritis
Dose-Optimization Trial of VXA-G1.1-NN in Healthy Volunteers
A Phase 1b, randomized, double-blind, dose-ranging trial to determine the safety of different dosing regimens an adenoviral-vector based norovirus vaccine (VXA-G1.1-NN) expressing GI.1 VP1 and dsRNA adjuvant administered orally…
- Trial name
- NCT03125473
- Testing
- VXA-G1.1-NN Oral Vaccine
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norwalk Gastroenteritis, Norovirus Infections
A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine
A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group.
- Trial name
- NCT04188691
- Testing
- Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）, Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）
- Where
- China
- Volunteers
- 510 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
Gastroenteritis Norovirus
Phase I Norovirus Challenge Model
This is a safety and infectivity study of experimental human Norovirus genogroup GII.4 administered to 48 healthy non-pregnant adults, 18-49 years of age, negative for COVID-19 by antigen testing at the time of norovirus…
- Trial name
- NCT04174560
- Testing
- Norovirus GII.4 Challenge Pool
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy
Infectivity of Norovirus in Groundwater-Human Challenge Study
Norwalk virus and related "Norwalk-like viruses" are the most common cause of outbreaks of stomach sickness (nausea, vomiting, diarrhea) in older children and adults in the United States.
- Trial name
- NCT00313404
- Testing
- Safety tested norovirus inoculum
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Emory University
Norovirus Infections, Norwalk Gastroenteritis
Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula Polymorpha)
The purpose of this study is to evaluate the Efficacy, Safety and Immunogenicity of the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha) in Healthy People Aged 6 Months to 13 Years After Vaccination
- Trial name
- NCT05916326
- Testing
- Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine，Recombinant (Hansenula polymorpha)
- Where
- 3 sites in China
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- National Vaccine and Serum Institute, China
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
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
Gastroenteritis
Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals.
- Trial name
- NCT05805618
- Testing
- Recombinant Norovirus Hexavalent Vaccine
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Syneos Health
Gastroenteritis Norovirus
Optimal Human Dose for GII.2 Norovirus (Snow Mountain) Challenge Studies
This is a phase I, randomized, double blind, as well as partially blinded (for Cohort 4), placebo-controlled safety, illness, and infection study of a new experimental human challenge stock of the Norovirus genogroup II, genotype…
- Trial name
- NCT02473224
- Testing
- Norovirus GII.2 Challenge
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Acute Gastroenteritis
Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)
The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate…
- Trial name
- NCT04563533
- Testing
- Low-dose vaccine, High-dose vaccine
- Where
- China
- Volunteers
- 580 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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.
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