Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Shigella4V2 · 1 trial · 1 indication
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of solicited AEs
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of unsolicited AEs
Safety and tolerability of the candidate vaccine Shigella4V2 as determined by occurrence, severity, and relationship of SAEs
Evaluation of geometric mean titers (GMT) and geometric mean ratios between baseline and 1-month post 2nd vaccination (GMR vs baseline) for serum IgG against the four Shigella serotypes included in the Shigella4V2 bioconjugate.
| Arm | Type | Description |
|---|---|---|
| low dose | EXPERIMENTAL | Participants receive 2 low-dose administrations of the investigational product |
| high dose | EXPERIMENTAL | Participants receive 2 high-dose administrations of the investigational product |
| Control | OTHER | Participants receive 2 administrations of MenACWY |
| Name | Type | Description |
|---|---|---|
| Shigella4V2 | BIOLOGICAL | Adjuvanted Shigella4V2 administrated at 2 different doses: low and high. |
| MenACWY | BIOLOGICAL | Control vaccine |
Inclusion Criteria: * Female or male aged 9 months (± 1 month) old at the time of the first vaccination. * Born full-term (i.e., after a gestation period of 37 to less than 42 full weeks). * Healthy by medical history, laboratory findings and physical examination before entering into the study (Par...
Shigella4V2 is an investigational bioconjugate vaccine being studied for the prevention of shigellosis, a bacterial infection that causes severe diarrhea. It is being evaluated in infants, with a completed Phase 2 trial enrolling 110 participants in Kenya. The vaccine is designed to expand safety and immunogenicity data in 9-month-old infants.
Shigella4V2 is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this vaccine candidate for shigellosis, with a completed Phase 2 trial in Kenya.
Shigella4V2 is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 2 trial, NCT06523231, has been completed, evaluating the vaccine in 110 infants aged 8 months and older in Kenya.
Shigella4V2 has one completed clinical trial, NCT06523231, titled 'Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.' This Phase 2 study enrolled 110 participants in Kenya and was a randomized, double-blind, controlled trial.
No, Shigella4V2 is a bioconjugate vaccine, not a monoclonal antibody. It is being developed to prevent shigellosis and is currently in Phase 2 clinical trials. The vaccine has been studied in a completed trial involving 110 infants in Kenya.