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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01960686 | RSV F Dose-Ranging Study in Women | PHASE2 | COMPLETED | 720 | — | — | Oct 1, 2013 | Apr 1, 2014 | May 26, 2016 | 10 | United States |
Serum IgG antibody concentrations as ELISA units (EUs) specific for the F protein antigen. Derived/calculated endpoints based on these data will include: * Geometric mean concentrations as EU (GMEU) * Geometric mean ratio (GMR) * Geometric mean fold-rise (GMFR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Numbers and percentages of subjects with solicited local and systemic adverse events over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters. In addition, Medically Attended Events, Serious Adverse Events, and Significant New Medical Conditions will be collected for six months.
| Arm | Type | Description |
|---|---|---|
| Low dose RSV F Vaccine with Dose 1 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: Low dose RSV F Antigen with Dose 1 of aluminum adjuvant Day 28: Placebo |
| Low dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant Day 28: Low dose RSV F Antigen content with Dose 2 of aluminum adjuvant |
| Low dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 3 of aluminum adjuvant |
| Low dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant Day 28: Low dose RSV F Antigen with Dose 4 of aluminum adjuvant |
| High dose RSV F Vaccine with Dose 2 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: High dose RSV F Antigen with Dose 2 of aluminum adjuvant Day 28: Placebo |
| High dose RSV F Vaccine with Dose 3 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: High dose RSV F Antigen with Dose 3 of aluminum adjuvant Day 28: Placebo |
| High dose RSV F Vaccine with Dose 4 of Aluminum Adjuvant | EXPERIMENTAL | Day 0: High dose RSV F Antigen content with Dose 4 of aluminum adjuvant Day 28: Placebo |
| Placebo | PLACEBO_COMPARATOR | Day 0: Placebo Day 28: Placebo |
| Name | Type | Description |
|---|---|---|
| Low dose RSV F Antigen | BIOLOGICAL | - |
| High dose RSV F Antigen | BIOLOGICAL | - |
| Dose 1 of Aluminum Adjuvant | BIOLOGICAL | - |
| Dose 2 of Aluminum Adjuvant | BIOLOGICAL | - |
| Dose 3 of Aluminum Adjuvant | BIOLOGICAL | - |
| Dose 4 of Aluminum Adjuvant | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: Subjects must meet the following criteria to be eligible to participate: 1. Healthy adult females, ≥ 18 and ≤ 35 years of age. "Healthy" shall be defined by the absence of any illness, acute or chronic, that requires ongoing systemic therapy for the control of symptoms or preve...