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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02296463 | A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age | PHASE1 | COMPLETED | 32 | — | — | Nov 1, 2014 | Apr 1, 2016 | Apr 28, 2016 | 4 | Canada |
Solicited local and systemic AEs over the 7 days post injection; and all AES, solicited and unsolicited, including adverse changes in clinical laboratory parameters, over 56 days post- first injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Derived/ calculated endpoints based on these data will include: Geometric mean EU (GMEU) Geometric mean ratio (GMR) Seroresponse rate (SRR)
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | Day 0: RSV F Vaccine with adjuvant, Day 28: RSV F Vaccine with adjuvant |
| Treatment Group B | EXPERIMENTAL | Day 0: RSV F Vaccine with adjuvant, Day 28: Hepatitis A Vaccine |
| Treatment Group C | EXPERIMENTAL | Day 0: RSV F Vaccine, Day 28: RSV F Vaccine |
| Treatment Group D | EXPERIMENTAL | Day 0: RSV F Vaccine, Day 28: Hepatitis A Vaccine |
| Treatment Group E | PLACEBO_COMPARATOR | Day 0: Placebo, Day 28: Hepatitis A Vaccine |
| Name | Type | Description |
|---|---|---|
| RSV F Vaccine with adjuvant (0.5mL injection) | BIOLOGICAL | - |
| RSV F Vaccine (0.5mL injection) | BIOLOGICAL | - |
| Hepatitis A Vaccine (0.5mL injection) | BIOLOGICAL | - |
| Placebo (0.5mL injection) | BIOLOGICAL | - |
Inclusion Criteria: 1. Healthy males and females, ≥24 months of age and \<72 months of age, without known chronic cardiopulmonary disease including especially persistent or frequently recurrent wheezing. 2. Free of other illnesses that are believed to increase the risks associated with influenza or...