Clinical Trial Search

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…

Primary: Number of Participants Who Experienced Norovirus Gastroenteritis (NVG) — 34; 37 Participants

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…

Primary: The Occurrence of Norovirus-associated Illness in Secretor Positive Participants Through Day 4 After Challenge. — 3; 2; 7; 0 Participants

Primary: Frequency of Norovirus Gastroenteritis (NVG) — 5; 4 Participants

Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) in Cohort 1 — 77.4; 63.5; 74.5; 85.7 percentage of participants

Primary: Number of Participants With Solicited Symptoms of Reactogenicity (Gastrointestinal [GI] and Systemic) — 20; 20; 2; 9 Participants

Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA) — 43.3; 62.1; 46.4; 35.5 percentage of participants

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

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…

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

Primary: Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 — 4; 5; 6; 5 participants

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…

Primary: Time to Initial Clinical Resolution of Norovirus Symptoms — 19; 11 days — p=0.459

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

Primary: Number of Participants (Mothers) With Any Solicited Symptoms of Reactogenicity for 1 Week Following Trial Dose — 15; 8; 5; 1 Participants

Primary: Percent of Healthcare Workers Testing Positive for COVID-19. — 0; 0 percentage of healthcare workers

Primary: Number of Infected Subjects — 0; 11 Participants — p=< 0.0001

Primary: Matched VE Participants — 26; 22; 16; 1 participants

Primary: Rates of Staphylococcus Aureus Acquisition: Percentage of Short Stay Participants Who Acquired MRSA or MSSA (or Both) During the Study Period — 17; 8 Participants

Primary: Number/Percentage of Subjects With Immune Response to Rotavirus Vaccine — 54; 40; 42; 37 Participants

Primary: Number of Participants With Rhinovirus-associated Illness Episodes — 63; 60 Participants

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

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

Primary: Reduction in Viral Load in the URT — 3.6; 3.3; 4.9; 4.1 log 10 copies/mL — p=0.7146

Primary: Cumulative Number of Reported Days-off Episodes in the Arm Due to Own Infectious Disease Over the Total Number of Follow-up Weeks in the Arm — 625; 418; 405 sick-leave…

Primary: MRSA Transmission — 0.20; 0.02; 0.11; 0.01 Proportion of swabs positive for MRSA