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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01447407 | Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine | PHASE1 | COMPLETED | 164 | — | — | Sep 1, 2011 | Dec 1, 2012 | Mar 4, 2020 | 1 | United States |
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
| Arm | Type | Description |
|---|---|---|
| NDV-3 vaccine with alum IM | ACTIVE_COMPARATOR | 300 ug Als3 and 0.5 mg Al as alum in PBS per dose, one dose administered IM |
| NDV-3 vaccine without alum IM | ACTIVE_COMPARATOR | 300 ug Als3 in PBS per dose, one dose administered IM |
| Placebo IM | PLACEBO_COMPARATOR | 0.5 mg Al as alum in PBS per dose, one dose administered IM |
| NDV-3 vaccine without alum ID | ACTIVE_COMPARATOR | 30 ug Als3 in PBS per dose, one dose administered ID |
| Name | Type | Description |
|---|---|---|
| NDV-3 vaccine with alum IM | BIOLOGICAL | One dose administered IM |
| NDV-3 vaccine without alum IM | BIOLOGICAL | One dose administered IM |
| Placebo with alum IM | BIOLOGICAL | One dose administered ID |
| NDV-3 vaccine without alum ID | BIOLOGICAL | One dose administered ID |
Inclusion Criteria: 1. Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent document prior to screening. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in E...