Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02645032 | Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine | PHASE1 | COMPLETED | 144 | — | — | May 19, 2016 | Feb 9, 2017 | Apr 28, 2020 | - | — |
Proportion of participants with local and systemic solicited adverse events (reactogenicity) and Proportion of participant with Serious Adverse Events (SAEs)
| Arm | Type | Description |
|---|---|---|
| Test group | EXPERIMENTAL | Two doses of Vi-DT (typhoid conjugate vaccine) will be administrated intramuscularly 4 weeks apart (Day 0 and Day 28). |
| Comparator group | ACTIVE_COMPARATOR | Biological/Vaccine: One dose of Typhim Vi® will be administrated intramuscularly at 1st dose (Day 0). One dose of VAXIGRIP® will be administrated intramuscularly at 2nd dose (Day 28). |
| Name | Type | Description |
|---|---|---|
| Vi-DT | BIOLOGICAL | Manufacturer: SK Chemicals Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial |
| Typhim Vi® | BIOLOGICAL | Manufacturer: Sanofi Pasteur Ingredient: Purified Vi-polysaccharide Appearance: colourless liquid Dose: 0.5mL/vial |
| VAXIGRIP® | BIOLOGICAL | Dose: Single injection, participants 6-35 months of age will receive 0.25 ml (half a dose), participants 36 months of age and older will receive 0.5ml (full dose) \*Participants less than 9 years of age, who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after the last follow-up visit of last participant in their age cohort. |
Inclusion Criteria: 1. Healthy male and female individual 2-45 years of age 2. Participants/Parents who have voluntarily given informed consent and/or assent. 3. Participants/Parents willing to commit complying with the study procedures of the investigator and available for the entire duration of s...