At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,312 enrolled
Drug / intervention
Q/LAIV (MEDI3250) +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Children
In Brief
A Phase 3 clinical trial evaluating Q/LAIV (MEDI3250), FluMist/B/Yamagata, and 1 other intervention for Healthy or Stable Chronic Illness. Completed, enrolled 2,312 participants across 110 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy or Stable Chronic Illness
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
First PostedMar 2010
Primary CompletionJul 2010
Study CompletionDec 2010
TodayJul 2026
First PostedMar 23, 2010
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.3 years ago
Interventions
Q/LAIV (MEDI3250)biological
10 \^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria
FluMist/B/Yamagatabiological
10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata
FluMist/B/Victoriabiological
10 \^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria