Study identifier:CD-VA-MEDI7510-1134
ClinicalTrials.gov identifier:NCT02115815
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1a Study to Evaluate the Safety of the Respiratory Syncytial Virus Vaccine MEDI7510 in Older Adults
Respiratory Syncytial Virus (RSV)
Phase 1
Yes
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All
246
Interventional
60 Years - 99 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Aug 2016 by MedImmune, LLC
MedImmune, LLC
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The purpose of this study is to determine if the administration of single ascending intramuscular doses of the RSV sF antigen or MEDI7510 will be safe and well tolerated in adults 60 years or older who are healthy or who have stable, chronic underlying medical conditions.
A phase 1a, first time in human, double-blind, randomized, placebo-controlled, cohort escalation study evaluating the safety and tolerability of a single ascending intramuscular dose of RSV sF or MEDI7510 or placebo. Approximately 146 participants will be enrolled at 3 US study centers and randomized in a 5:1 ratio by cohort as described below: Cohort 1: RSV sF 20 microgram (mcg) (n=20) or placebo (n=4) Cohort 1a: MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 2: RSV sF 50 mcg (n=20) or placebo (n=4) Cohort 2a: MEDI7510 (50 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4) Cohort 3: 80 mcg RSV sF (n=20) or placebo (n=4) Cohort 3a: MEDI7510 (80 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A (GLA) + 2% weight per volume stable emulsion (n=20) or placebo (n=4)
Location
Location
Miami, FL, United States, 33143
Location
Orlando, FL, United States, 32806
Location
Rockville, MD, United States, 20850
Arms | Assigned Interventions |
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Placebo Comparator: Placebo Sterile saline for human use from commercial source, liquid | Biological/Vaccine: Placebo Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1. |
Experimental: RSV sF 20 mcg Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. | Biological/Vaccine: RSV sF 20 mcg Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1. |
Experimental: MEDI7510 (20 mcg RSV sF) 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. | Biological/Vaccine: MEDI7510 (20 mcg RSV sF) Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1. |
Experimental: RSV sF 50 mcg Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. | Biological/Vaccine: RSV sF 50 mcg Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1. |
Experimental: MEDI7510 (50 mcg RSV sF) 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. | Biological/Vaccine: MEDI7510 (50 mcg RSV sF) Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1. |
Experimental: RSV sF 80 mcg Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. | Biological/Vaccine: RSV sF 80 mcg Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1. |
Experimental: MEDI7510 (80 mcg RSV sF) 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. | Biological/Vaccine: MEDI7510 (80 mcg RSV sF) Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1. |
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