Study identifier:MI-CP206
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 years of Age
healthy or stable underlying chronic medical condition
Phase 3
Yes
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All
1800
Interventional
18 Years - 49 Years
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Dec 2011 by MedImmune, LLC
MedImmune, LLC
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No locations available
Arms | Assigned Interventions |
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Experimental: Q/LAIV-BFS (MEDI8662) Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006). | Biological/Vaccine: Q/LAIV-BFS (MEDI8662) A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0. |
Active Comparator: FluMist/B/Yamagata FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006) | Biological/Vaccine: FluMist/B/Yamagata FluMist/B/Yamagata - 0.2 mL dose at Day 0 |
Active Comparator: FluMist/B/Victoria FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004). | Biological/Vaccine: FluMist/B/Victoria FluMist/B/Victoria - 0.2 mL dose at Day 0 |