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
-
No locations available
Arms | Assigned Interventions |
---|---|
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. |