Clinical trials: Norovirus
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 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
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
Cellulite
Proof of Concept (POC) Study of the Soliton Rapid Acoustic (RAP) for the Treatment of Cellulite
Feasibility study is to evaluate the safety, tolerability and efficacy of Soliton's Rapid Acoustic Pulse (RAP) device for the treatment of cellulite
- Trial name
- NCT03981198
- Testing
- Soliton Rapid Acoustic Pulse (RAP)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Soliton
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
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.
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, 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
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.
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
Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55, inclusive, and to assess the safety and…
- Trial name
- VXA-NVV-105 (NCT04875676)
- Testing
- VXA-G1.1-NN
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus Infections
A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old
The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.
- Trial name
- NCT06944717
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS, VXA G1.1 NN-T
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vaxart
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
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
Healthy Volunteers
Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4 bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE) due to genotype-specific (GI.1 and GII.4) NoV…
- Trial name
- NCT02669121
- Testing
- NoV GI.1/GII.4 Bivalent VLP Vaccine
- Where
- United States
- Volunteers
- 4,748 people, healthy volunteers welcome
- Sponsor
- Takeda
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
Symptom Assessment
ESSENCE is a Quality Improvement Study That Evaluates the Impact of Ada's AI-powered Core Symptom Assessment Technology on Clinical Workflow and Individual Healthcare Guidance, Following the November 2021 Integration of the Tool Into the CUF Hospital Network. Study Duration Nov 2024-Oct 2025
A 1.5.1 Study title ESSENCE Study: E-health Self Symptom assEssmeNt as a front door and facilitator of CarE A 1.5.2 Investigational device 'Ada Assess' (CE-marked), 'Ada Connect' (a software integrating with CE-marked medical…
- Trial name
- ESSENCE (NCT06846957)
- Where
- Portugal
- Volunteers
- 1,470 people
- Sponsor
- Ada Health GmbH
Norovirus Infections
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity…
- Trial name
- NCT07254728
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- 5 sites in South Africa
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus Infections
Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine
A Phase 1b, multicenter, randomized, double-blind, placebo-controlled study to determine the safety and immunogenicity of an adenoviral-vector based oral norovirus vaccine expressing GI.1 VP1 administered orally to healthy older…
- Trial name
- VXA-NVV-104 (NCT04854746)
- Testing
- VXA-GI.1.NN
- Where
- 3 sites in United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Vaxart
Norovirus Infections
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
Subjects will receive multiple sub-doses over a 4-hour period to deliver a total overall dose of 1E11. Evaluations of immunogenicity, safety, and tolerability will be evaluated.
- Trial name
- (VXA-G1-1-NN) (NCT05213728)
- Testing
- VXA-G1.1-NN
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Vaxart