Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RSV sF · 1 trial · 1 indication
Solicited symptoms: tenderness or soreness at site of injection, pain at site of injection, fatigue or tiredness, headache, generalized muscle aches, swelling at the site of injection, redness at the site of injection, fever greater than or equal to (\>=) 100.4 degrees F by any route from Day 1 to Day 7.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study product and Day 361 that were absent before treatment or that worsened relative to pretreatment state. An AESI was one of scientific and medical interest specific to understanding of study product and may have required close monitoring and rapid communication by investigator to the sponsor. A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving investigational product and was assessed by investigator as medically significant.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Sterile saline for human use from commercial source, liquid |
| RSV sF 20 mcg | EXPERIMENTAL | Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (20 mcg RSV sF) | EXPERIMENTAL | Participants will receive single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A \[GLA\] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| RSV sF 50 mcg | EXPERIMENTAL | Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (50 mcg RSV sF) | EXPERIMENTAL | Participants will receive single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| RSV sF 80 mcg | EXPERIMENTAL | Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (80 mcg RSV sF) | EXPERIMENTAL | Participants will receive a single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA + 2% weight per volume stable emulsion) by intramuscular injection on Day 1. |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1. |
| RSV sF 20 mcg | BIOLOGICAL | Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (20 mcg RSV sF) | BIOLOGICAL | Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1. |
| RSV sF 50 mcg | BIOLOGICAL | Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (50 mcg RSV sF) | BIOLOGICAL | Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1. |
| RSV sF 80 mcg | BIOLOGICAL | Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
| MEDI7510 (80 mcg RSV sF) | BIOLOGICAL | Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1. |
Inclusion Criteria: * Age greater than or equal to 60 years * Written informed consent and any locally required authorization obtained prior to any protocol related procedures * Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or homebound * Weight at or above 110 Pounds ...
RSV sF is being developed for the prevention of respiratory syncytial virus (RSV) in older adults. It is an investigational monoclonal antibody studied in a Phase 1 clinical trial that enrolled 246 healthy volunteers aged 60 years and older in the United States.
RSV sF is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca conducted the Phase 1 trial of the candidate in older adults.
RSV sF is in Phase 1 clinical development. The only reported trial, NCT02115815, has been completed. No Phase 2 or later trials have been reported, and the candidate has not been approved for any indication.
RSV sF has been studied in one completed Phase 1 trial, NCT02115815, titled "A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults." The trial enrolled 246 participants aged 60 and older in the United States and was randomized, double-blind, and placebo-controlled.