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MEDI7510 · 1 trial · 1 indication
Solicited symptoms are events that are considered likely to occur post dosing and included the local reaction (pain, tenderness or soreness, redness, and swelling at the site of injection) to investigational product (IP) injection and systemic symptoms (fever greater than or equal to \[\>=\] 100.4°F \[\>=38°C\] by any route, headache, generalized muscle aches, and fatigue or tiredness) that might be related to IP injection. Solicited symptoms were not coded using Medical Dictionary for Regulatory Activities (MedDRA) and summarized regardless of whether or not they are treatment emergent. The percentage of participants with solicited symptoms were recorded during Days 1 (day of dosing) through 7.
An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Treatment-emergent were the events between administration of study drug and including the follow-up period through Day 29. The AEs were summarized using the Medical Dictionary for Regulatory Activities version 18.1.
A serious adverse event (SAE) was an AE resulting in any of following reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk), persistent or significant disability/incapacity, congenital anomaly, and a medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above.
A NOCD was a newly diagnosed medical condition that is of a chronic, ongoing nature. It was observed after receiving study drug and was assessed by investigator as medically significant. All NOCDs were recorded from the time of dosing through the day of the last participant contact (Day 361 visit).
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. Treatment emergent AESIs were collected from the time of dosing through the day of the last participant contact (Day 361 visit).
| Arm | Type | Description |
|---|---|---|
| MEDI7510 (120 mcg sF + 1 mcg GLA), Cohort 1 | EXPERIMENTAL | Participants will receive a single dose of MEDI7510 (120 microgram \[mcg\] respiratory syncytial virus \[RSV\] soluble fusion protein \[sF\] plus 1.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by intramuscular (IM) injection on Day 1. |
| MEDI7510 (120 mcg sF + 2.5 mcg GLA), Cohort 2 | EXPERIMENTAL | Participants will receive a single dose of MEDI7510 (120 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV or MEDI7510 plus placebo administered by IM injection in contralateral arms on Day 1. |
| MEDI7510 (120 mcg sF + 5 mcg GLA), Cohort 3 | EXPERIMENTAL | Participants will receive a single dose of MEDI7510 (120 mcg RSV sF plus 5.0 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) plus IIV or MEDI7510 plus placebo administered by IM injection in contralateral arms on Day 1. |
| MEDI7510 (80 mcg sF + 2.5 mcg GLA), Cohort 4 | EXPERIMENTAL | Participants will receive a single dose of MEDI7510 (80 mcg RSV sF plus 2.5 mcg glucopyranosyl lipid A in 2% volume per volume stable emulsion) administered by IM injection on Day 1. |
| Inactivated Influenza Vaccine (IIV) | ACTIVE_COMPARATOR | Participants will receive a single dose of IIV by intramuscular injection in contralateral arms on Day 1. |
| Name | Type | Description |
|---|---|---|
| MEDI7510 | BIOLOGICAL | RSV sF antigen plus adjuvant |
| IIV | BIOLOGICAL | Marketed Inactivated Influenza Vaccine |
Inclusion Criteria: * Age greater than or equal to 60 years * Ambulatory or ambulatory with assistance (not institutionalized, bedridden, or homebound) * Weight greater than 90 lbs * Hemoglobin greater than or equal to 10.5 g/dL for women and greater than or equal to 11 g/dL for men * Subject able ...
MEDI7510 is an investigational monoclonal antibody developed by AstraZeneca PLC for respiratory syncytial virus, or RSV. It was studied as an active-controlled, randomized, double-blind Phase 1 candidate in older adults aged 60 years and above. It is not an approved product and remains in clinical development.
MEDI7510 was studied for respiratory syncytial virus, or RSV, in older adults. The single Phase 1 trial enrolled 363 healthy volunteers aged 60 years and older in the United States and evaluated safety and immunogenicity in that population. No approved use has been established for MEDI7510.
MEDI7510 is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 study of the candidate in older adults. The asset is an investigational monoclonal antibody directed at respiratory syncytial virus.
MEDI7510 is in Phase 1. One Phase 1 trial has been completed, and no trials are currently active. The completed study was randomized, double-blind, and active-controlled, enrolling 363 healthy volunteers aged 60 years and older with respiratory syncytial virus as the condition under study.
MEDI7510 has been evaluated in one completed Phase 1 trial, NCT02289820, titled A Study to Evaluate the Safety and Immunogenicity of MEDI7510 in Older Adults. It enrolled 363 participants aged 60 years and older in the United States, was randomized, double-blind, and active-controlled, and has completed.