Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart. The hypotheses for this study are: * The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and Al(OH)3. * Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose. * The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
Timeframe: Day 0 up to Day 7
Number of Participants With Solicited Local AEs Post Dose 2
Timeframe: Day 28 up to Day 35
Number of Participants With Solicited Systemic AEs Post Dose 1
Timeframe: Day 0 up to Day 7
Number of Participants With Solicited Systemic AEs Post Dose 2
Timeframe: Day 28 up to Day 35
Number of Participants With Unsolicited AEs Post Dose 1
Timeframe: Baseline up to Day 28 (Pre-dose 2)
Number of Participants With Unsolicited AEs Post Dose 2
Timeframe: Day 28 up to Day 56 (Post dose 2)
Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
Timeframe: Baseline up to Day 35
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
Timeframe: Baseline up to 365 Days after post dose 2 (Day 393)