Phase 1 N=16 Evaluation of Infectivity and Illness of Norwalk GI.1 Virus Lot 001-09NV in the Human Challenge Model
Norovirus Infection
Primary: Frequency of Norovirus Gastroenteritis (NVG) — 5; 4 Participants
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Phase 1 N=48 Phase I Norovirus Challenge Model
Gastroenteritis Norovirus
Primary: The Occurrence of Norovirus-associated Illness in Secretor Positive Participants Through Day 4 After Challenge. — 3; 2; 7; 0 Participants
Phase 2 N=165 Norovirus Challenge Study
Norovirus Infections
Primary: Number of Participants Who Experienced Norovirus Gastroenteritis (NVG) — 34; 37 Participants
Phase 2 N=132 Norovirus Bivalent-Vaccine Efficacy Study
Prevention From Norovirus Infection
Primary: Percentage of Participants With Viral AGE Clinical Illness and Fecal Virus Excretion Detected by RT-PCR OR 4-Fold Rise In Anti-GII.4 Norovirus P Particle Antibody Titer…
Phase 2 N=4,748 Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
Healthy Volunteers
Primary: Number of Participants With Moderate or Severe Acute Gastroenteritis (AGE) Occurring for >7 Days After Dosing Due to GI.1 or GII.4 Norovirus Strains (Excluding…
Phase 2 N=31 NNITS-Nitazoxanide for Norovirus in Transplant Patients Study
Gastroenteritis Norovirus
Primary: Time to Initial Clinical Resolution of Norovirus Symptoms — 19; 11 days — p=0.459
Phase 1 N=102 Bivalent Norovirus Vaccine Study
Gastroenteritis
Primary: Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 — 4; 5; 6; 5 participants
Phase 2 N=135 A Study to Determine the Safety and Immunogenicity of Bivalent GI.1 and GII.4 Vaccines in Healthy Volunteers
Norovirus Infections
Primary: Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic) — 20; 20; 2; 9 Participants
Phase 2 N=454 Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults
Norovirus Prevention
Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection — 7.8; 64.1; 72.7; 7.8 percentage of participants
Phase 2 N=30 Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
Norovirus Infections
Primary: Viral-capsid Protein 1 (VP1)-Specific Antibody Secreting Cells (ASC) by Enzyme-linked Immunospot (ELISpot) Assay — 1.3; 0.5; 0.3; 127.6 Spot Forming Units per 10^6 PBMC
N/A N=67 Epidemiology Non-cholera Vibrio Infections
Vibrio Infections
Primary: Number of Participants With Diagnosed Non-cholerae or Non-O1/O139 Vibrio Infection — 20; 7; 2; 18 Participants
Phase 2 N=840 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
Norovirus
Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1 — 77.4; 63.5; 74.5; 85.7 percentage of participants
Phase 2 N=420 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Healthy Volunteers · Norovirus, Prevention
Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) — 43.3; 62.1; 46.4; 35.5 percentage of participants
Phase 2 N=528 Long-Term Immunogenicity of the Norovirus GI.1/GII.4 Bivalent Virus-like Particle (VLP) Vaccine (NoV Vaccine) in Adults
Healthy Volunteers · Norovirus
Primary: Geometric Mean Blocking Titers 50 Percent (%) (GMBT50) of Anti-norovirus GI.1 VLP Antibodies as Measured by Histo-Blood Group Antigen HBGA Blocking Assay — 27.4; 18.3…
Phase 2 N=320 Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population
Norovirus
Primary: Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by…
Phase 3 N=1,756 Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection
Enterovirus · Rhinovirus
Primary: Time From First Dose to Symptom Response Over 21 Days of Follow up Based Upon the FLU-PRO Instrument (Novel Endpoint) — 122.5; 137.1 hours — p=0.4009
Phase 1 N=76 A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
Norovirus Infections
Primary: Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose — 15; 8; 5; 1 Participants
Phase 2 N=50 Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
Norovirus · Healthy Participants
Primary: Number of Participants With Serum Samples Obtained on Day 8 for Assessment of Seropositivity for Both Anti-NoV GI.1 VLP and GII.4 VLP Antibodies — 48 participants
N/A N=983 Probiotics and Infections in Conscripts in Military Service
Respiratory Tract Infections · Gastrointestinal Diseases · Asthma Exacerbations
Primary: Number of Sick Days — p=< 0.05
N/A N=1,555 Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
Gastroenteritis · Dehydration
Primary: Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age — 428 Participants
Phase 4 N=1,384 Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Rotavirus Infection
Primary: Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay — 186; 182; 175; 191 participants
Phase 4 N=259 Clinical Trial of Efficacy and Safety of Ergoferon in the Treatment of Viral Intestinal Infections in Children
Viral Intestinal Infection
Primary: Average Diarrhea Duration. — 43.4; 54.7 hours — p=0.004
N/A N=374 Vaccine Effectiveness of RV1 in a Naïve Population
Rotavirus Infections · Gastroenteritis · Diarrhea
Primary: Matched VE Participants — 26; 22; 16; 1 participants
Phase 1 N=27 CampETEC Hyperimmune Bovine Colostrum (HBC)
Healthy Volunteer
Primary: Incidence of Adverse Events — 1; 1; 0; 1 events
N/A N=1,545 Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study
Infectious Gastroenteritis
Primary: Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel — 434; 19 Participants
Phase 2 N=260 Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness
Severe Acute Respiratory Illness
Primary: Time to Hospital Discharge — 7.1; 7.5 Days — p=0.5634
N/A N=33 The Natural History of Viral Upper Respiratory Infections in Children Aged 6 to Less Than 14 Years
Upper Respiratory Infection · Common Cold
Primary: Local Leukotriene Levels — 440; 368; 440; 619 pg/ml
N/A N=229 USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19
Covid19
Primary: Number of Infected Subjects — 0; 11 Participants — p=< 0.0001
N/A N=334 Effect of Probiotic on Rhinovirus Induced Colds
Common Cold
Primary: Number of Participants With Rhinovirus-associated Illness Episodes — 63; 60 Participants
Phase 2 N=202 Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers
HIV Infection · Rotavirus Infection
Primary: Percentage of Participants Developing New Grade >=3 Adverse Events — 1.6; 4.7; 13.5; 12.8 Percentage of participants — p=0.62