NCT02508194

A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

A Phase 2b Randomized, Double-blind Study to Evaluate the Efficacy of MEDI7510 for the Prevention of Acute Respiratory Syncytial Virus-associated Respiratory Illness in Older Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,900 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 60 Years – 99 Years
• Healthy volunteers: Accepted

Summary

This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.

Detailed description

A Phase 2b, double-blind, randomized, and controlled study to evaluate the efficacy of MEDI7510 in approximately 1,900 adult participants, globally, 60 years or older. Participants will be randomized in a 1:1 ratio to receive a single intramuscular dose of each of 2 study vaccines in contralateral arms: MEDI7510 + IIV or placebo + IIV in Season 1. Participants who receive MEDI7510 in the Northern Hemisphere will be re-randomized and blinded in Season 2 to receive either MEDI7510 + IIV or placebo + IIV in a 1:1 ratio. Clinical efficacy will not be assessed in Season 2; however the safety of revaccination will be assessed in Season 2.

Conditions

• Respiratory Syncytial Virus

Interventions

Type	Name	Description
BIOLOGICAL	MEDI7510	RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant
BIOLOGICAL	IIV	Marketed Inactivated Influenza Vaccine
OTHER	Placebo	Sterile Saline

Timeline

• Start date: 2015-09-29
• Primary completion: 2016-09-09
• Completion: 2016-11-07
• First posted: 2015-07-24
• Last updated: 2017-12-26
• Results posted: 2017-12-20

Locations

61 sites across 7 countries: United States, Canada, Chile, Estonia, Latvia, Lithuania, South Africa

Regulatory

• FDA-regulated drug study