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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02608502 | A Study to Evaluate the Efficacy of an RSV F Vaccine in Older Adults | PHASE3 | COMPLETED | 11,850 | — | — | Nov 1, 2015 | Dec 1, 2016 | Jul 19, 2022 | 60 | United States |
| NCT02593071 | Safety and Immunogenicity of the RSV-F Vaccine in Older Adults Previously Treated With the Same Vaccine or Placebo in the Prior Year. | PHASE2 | COMPLETED | 1,330 | — | — | Oct 1, 2015 | Nov 1, 2016 | May 27, 2022 | 10 | United States |
| NCT02266628 | Placebo- Controlled Study to Evaluate the Safety and Immunogenicity of the RSV-F Vaccine in Elderly Adults | PHASE2 | COMPLETED | 1,599 | — | — | Oct 1, 2014 | Mar 1, 2016 | May 27, 2022 | 10 | United States |
| NCT01704365 | RSV-F Vaccine Dose Ranging Study in Young Women | PHASE2 | COMPLETED | 330 | — | — | Oct 1, 2012 | May 1, 2013 | Mar 7, 2014 | 4 | United States |
Defined by the presence of at least three (3) of: cough, wheezing (or worsening in baseline wheezing), new sputum production (or increase in baseline sputum production), new (or worsening) shortness of breath, and observed tachypnea (≥20 breaths per minute); plus RT-PCR-confirmed RSV infection documented within five days of symptom onset.
Defined as solicited local and systemic AEs over the 7 days post-injection; all adverse events, solicited and unsolicited over 56 days after dosing; and MAEs, SAEs, and SNMCs over one year post dosing.
Derived/calculated endpoints based on these data will include: * Geometric mean concentration as EU (GMEU) * Geometric mean ratio (GMR) * Seroresponse rate (SRR) * Proportion of subjects with two (2)- and 4-fold seroconversion rates ( SCR2 and SCR4, respectively)
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) * Seroresponse rate (SRR)
Defined by any one of rhinorrhea, nasal congestion, pharyngitis, cough, wheezing (or increase in baseline wheezing), sputum production (or increase in the change in nature of baseline sputum production), or new (or worsening) shortness of breath; plus RT-PRC-confirmed RSV infection documented within three days of symptom onset.
Solicited local and systemic AEs over the seven days post-injection; and all adverse events, solicited and unsolicited, including adverse changes in clinical laboratory parameters over 56 days post injection. In addition, MAEs, SAEs, and SNMCs will be collected for one year.
Immunogenicity will be measured using derived / calculated endpoints based on: * Geometric mean titer (GMT) * Geometric mean ratio (GMR) * Seroconversion rate (SCR) * Seroresponse rate (SRR)
Number (and percentage) of subjects with solicited local and systemic Adverse Events over the seven days post-injections; all adverse events, solicited and unsolicited over 56 days post-first injection. Significant New Medical Conditions, Medically Attended Events and Serious Adverse Events will be collected for six months
| Arm | Type | Description |
|---|---|---|
| Treatment Group A | EXPERIMENTAL | RSV-F Vaccine (0.5mL Injection) |
| Treatment Group B | PLACEBO_COMPARATOR | Phosphate Buffer Placebo (0.5mL Injection) |
| Group A | EXPERIMENTAL | Low dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28) |
| Group B | EXPERIMENTAL | Low dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28) |
| Group C | EXPERIMENTAL | Low dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28) |
| Group D | EXPERIMENTAL | Low dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28) |
| Group E | EXPERIMENTAL | High dose RSV-F Vaccine with Adjuvant (Day 0 and Day 28) |
| Group F | EXPERIMENTAL | High dose RSV-F Vaccine with Adjuvant (Day 0); Placebo (Day 28) |
| Group G | EXPERIMENTAL | High dose RSV-F Vaccine without Adjuvant (Day 0 and Day 28) |
| Group H | EXPERIMENTAL | High dose RSV-F Vaccine without Adjuvant (Day 0); Placebo (Day 28) |
| Group J | EXPERIMENTAL | Low dose RSV-F Vaccine with Adjuvant \[Bedside Mixing\] (Day 0 \& Day 28) |
| Group K | PLACEBO_COMPARATOR | Placebo (Day 0 and Day 28) |
| Name | Type | Description |
|---|---|---|
| RSV-F Vaccine | BIOLOGICAL | - |
| Phosphate Buffer Placebo | BIOLOGICAL | - |
| Saline Placebo | BIOLOGICAL | - |
| Low dose RSV-F Vaccine with Adjuvant | BIOLOGICAL | 0.5mL IM Injection |
| Low dose RSV-F Vaccine without Adjuvant | BIOLOGICAL | 0.5ml IM Injection |
| High dose RSV-F Vaccine with Adjuvant | BIOLOGICAL | 0.5mL IM Injection |
| High dose RSV-F Vaccine without Adjuvant | BIOLOGICAL | 0.5mL IM Injection |
| Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing] | BIOLOGICAL | 0.5mL IM Injection |
| Placebo | BIOLOGICAL | 0.5mL IM Injection |
Inclusion Criteria: 1. Males and females ≥60 years of age who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that provide minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living. Subjec...