Clinical trials: 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
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
Norovirus
Recombinant, Bivalent, Norovirus Vaccine Study
This clinical study will evaluate the vaccine candidate rNV-2v, which is under development to prevent disease triggered by noroviruses. Noroviruses are one of the leading causes of gastrointestinal diseases in the world.
- Trial name
- NCT05508178
- Testing
- Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (100 µg), Norovirus GI.4 / GII.4 Bivalent VLP Vaccine (300 µg)
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Icon Genetics GmbH
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
Norovirus Infections
Human Breastmilk in Young Children With Norovirus Infection of the Gut
Human Breast milk in young children with Norovirus Infection
- Trial name
- NCT02371538
- Testing
- Donor Breastmilk
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Norovirus
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population
The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.
- Trial name
- NCT02661490
- Testing
- Norovirus GI.1/GII.4 Bivalent VLP Vaccine, 0.9% sodium chloride (saline)
- Where
- 10 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Norovirus
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for further development in children.
- Trial name
- NCT02153112
- Testing
- GI.1/GII.4 (15/15), GI.1/GII.4 (15/50), GI.1/GII.4 (50/50)
- Where
- 12 sites in Colombia, Finland and 1 more
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Takeda
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 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)
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
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
Norovirus, Healthy Participants
Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
The purpose of this study is to collect serum samples to evaluate serologic assays and to establish proficiency panels for serologic assays used for assessment of post vaccination immune response after intramuscular (IM)…
- Trial name
- NCT02475278
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Healthy Volunteers, Norovirus, Prevention
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for…
- Trial name
- NOR-107 (NCT02038907)
- Testing
- Hepatitis A Vaccine, Norovirus Bivalent VLP Vaccine
- Where
- 2 sites in Belgium
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Phase 1 Norwalk Vaccine Study
Randomized, double blind, multi-site, study in healthy adults, comparing safety and immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with placebo controls Primary Objective: Safety as…
- Trial name
- NCT00806962
- Testing
- Adjuvant/Excipients, Norwalk VLP Vaccine
- Where
- 4 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- LigoCyte Pharmaceuticals, Inc.
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)
Norovirus Infections
Dose Range Evaluation of Norovirus Challenge Pool (GII.4, CIN-1)
The purpose of this study is to determine a suitable dose of the human norovirus GII.4 challenge pool(CIN-1;031693) that induces illness in approximately 50% of susceptible subjects that would be useful for evaluation of vaccines…
- Trial name
- CIN-002 (NCT01435811)
- Testing
- Norovirus challenge pool (GII.4, CIN-1)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Rotavirus Infection, Adenoviridae Infection
Study of Nitazoxanide Suspension in the Treatment of Diarrhea Caused by Enteric Viruses in Children
The purpose of this study is to determine the effect of nitazoxanide suspension in treating diarrhea caused by enteric viruses in children less than 12 years of age.
- Conditions
- Rotavirus Infection, Adenoviridae Infection, Norovirus Infection
- Trial name
- NCT00302640
- Testing
- Alinia (nitazoxanide)
- Volunteers
- 50 people
- Sponsor
- Romark Laboratories L.C.