NCT01091246

A Study to Evaluate the Immunogenicity of Quadrivalent Live Attenuated Influenza Vaccine (LAIV) in Children

A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,312 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to demonstrate the immunologic noninferiority of Q/LAIV to FluMist in children 2 to 17 years of age.

Detailed description

The randomized, double-blind study was designed to demonstrate the immunologic noninferiority of Q/LAIV compared to FluMist in children 2-17 years by comparing the strain-specific post-dose geometric mean titers of hemagglutination inhibition antibodies. Children were randomized 3:1:1 to receive Q/LAIV or one of two FluMist vaccines. Subjects 9-17 years of age received a single dose, and those 2-8 years of age received two doses one month apart. Serum was obtained 1 month after dose 1 except in influenza vaccine-naive subjects 2-8 years old, when it was obtained after dose 2. Safety and tolerability were also assessed.

Conditions

• Healthy or Stable Chronic Illness

Interventions

Type	Name	Description
BIOLOGICAL	Q/LAIV (MEDI3250)	10 \^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria
BIOLOGICAL	FluMist/B/Yamagata	10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata
BIOLOGICAL	FluMist/B/Victoria	10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-07-01
• Completion: 2010-12-01
• First posted: 2010-03-23
• Last updated: 2011-09-26
• Results posted: 2011-09-22

Locations

110 sites across 1 country: United States