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 an investigational monoclonal antibody being developed for Respiratory Syncytial Virus (RSV). It is intended for use in older adults, as the clinical trial enrolled participants aged 60 years and older. The drug is currently in Phase 1 clinical development.
RSV sF is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety of this investigational monoclonal antibody for Respiratory Syncytial Virus.
RSV sF is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety in older adults with Respiratory Syncytial Virus.
RSV sF has one completed clinical trial, identified as NCT02115815. This Phase 1 study evaluated the safety of the Respiratory Syncytial Virus vaccine MEDI7510 in older adults. The trial enrolled 246 participants in the United States and was placebo-controlled, randomized, and double-blind.
Yes, RSV sF is the same as MEDI7510. The clinical trial NCT02115815, which evaluated the safety of RSV sF, is titled 'A Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults.' Both names refer to the same investigational monoclonal antibody.