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Norovirus Infections clinical trials

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NCT ID: NCT06211621 Completed - COVID-19 Pandemic Clinical Trials

Admission Pattern Among Children With Gastro-intestinal Infections Before and During the Covid-19 Pandemic

Start date: January 2017
Phase:
Study type: Observational

During the Covid-19 pandemic, admission patterns for infections other than Covid-19 have changed dramatically among children worldwide. Particularly admissions due to respiratory infections and later invasive streptococcal infections have been well documented. However, few studies have compared rates af gastro-intestinal infections during the pandemic with the previous years. This study aims to compare the number and characteristics of children hospitalized with gastrointestinal infections before the COVID-19 pandemic, to the first strict lockdown in 2020 and to the second, less strict lockdown in 2021. A retrospective review of medical records will be performed, of patients aged 1 month to 5 years admitted with gastroenteritis at the pediatric department at Slagelse Hospital in Denmark over a period from 2017 to 2021.

NCT ID: NCT05916326 Not yet recruiting - Clinical trials for Norovirus Infections

Phase III Clinical Trial to Evaluate the Human Norovirus Bivalent (GⅠ.1/GⅡ.4)Vaccine,Recombinant (Hansenula Polymorpha)

Start date: June 2023
Phase: Phase 3
Study type: Interventional

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

NCT ID: NCT05626803 Active, not recruiting - Clinical trials for Norovirus Infections

A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers

Start date: February 28, 2022
Phase: Phase 2
Study type: Interventional

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. Bivalent GI.1 and GII.4 vaccines are being investigated for the prevention of noroviral gastroenteritis caused by norovirus GI.1 and GII.4.

NCT ID: NCT05213728 Completed - Clinical trials for 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

(VXA-G1-1-NN)
Start date: January 24, 2022
Phase: Phase 1
Study type: Interventional

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. The active period consists of data collection at Day 1, Day 8, and Day 29. Safety follow-up continues by phone screen at Day 180 and Day 365.

NCT ID: NCT05212168 Completed - Clinical trials for Norovirus Infections

Norovirus Challenge Study

G1-1 Challenge
Start date: January 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

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). Healthy adults will be randomized in a 1:1 ratio to receive one oral dose of vaccine or placebo. - Arm 1: VXA-G1.1-NN oral vaccine tablets [1x1011 IU±0.5 log] - Arm 2: Placebo tablets similar in appearance and number to active vaccine tablets Approximately 28 days post-vaccination, subjects will be admitted to an isolation ward and challenged with the NV GI.1 Norwalk challenge strain. After challenge, subjects will be monitored for signs and symptoms of acute gastroenteritis (AGE) from Day 29 to discharge. At 4 days post challenge (Day 33) asymptomatic subjects will be discharged from the isolation ward and will be followed in a series of outpatient visits and telephone calls. Symptomatic subjects may be kept in the isolation ward for up to an additional 3 days.

NCT ID: NCT04941261 Recruiting - Clinical trials for Norovirus Infections

Clinical Trial to Evaluate the Recombinant Norovirus Bivalent (GI. 1 / GII. 4) Vaccine (Hansenula Polymorpha)

Start date: June 30, 2021
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT04875676 Completed - Clinical trials for Norovirus Infections

Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines

VXA-NVV-105
Start date: April 30, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

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 tolerability of VXA- G1.1-NN with repeat-dose administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55, inclusive

NCT ID: NCT04854746 Completed - Clinical trials for Norovirus Infections

Ph 1b: Safety & Immunogenicity of Ad5 Based Oral Norovirus Vaccine

VXA-NVV-104
Start date: April 26, 2021
Phase: Phase 1
Study type: Interventional

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 adult volunteers 55-80 years of age. The study is designed to assess the safety, tolerability, immunogenicity, and efficacy of 3 dose levels of vaccine with a 2-dose vaccination schedule (4 weeks apart) in healthy older adults (55 to 80 years old)

NCT ID: NCT04188691 Completed - Clinical trials for Norovirus Infections

A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

Start date: November 28, 2019
Phase: Phase 1
Study type: Interventional

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. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1. The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.

NCT ID: NCT02371538 Terminated - Clinical trials for Norovirus Infections

Human Breastmilk in Young Children With Norovirus Infection of the Gut

Start date: October 2014
Phase: N/A
Study type: Interventional

Human Breast milk in young children with Norovirus Infection