CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,800 enrolled
Drug / intervention
Q/LAIV-BFS (MEDI8662) +2 morebiological
Likely dose
Q/LAIV-BFS (MEDI8662) 0.2 mLfrom 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.

Search/NCT00952705
NCT00952705Phase 3Completed
CompareCT.gov

A Randomized, Partially Blind Active Controlled Study to Evaluate the Immunogenicity of MEDI8662 in Adults 18 to 49 Years of Age

MedImmune LLC·interventional·Posted Aug 6, 2009·Updated May 3, 2018

In Brief

A Phase 3 clinical trial evaluating Q/LAIV-BFS (MEDI8662), FluMist/B/Yamagata, and 1 other intervention for Healthy or Stable Underlying Chronic Medical Condition. Completed, enrolled 1,800 participants across 18 sites.

Detailed Summary

The purpose of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV-BFS; MEDI8662) was at least as immunogenic as two different forms of the commercial vaccine, FluMist, by comparing the strain-specific antibody levels in the blood.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy or Stable Underlying Chronic Medical Condition
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartAug 1, 2009
Primary CompletionJan 1, 2010
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.9 years ago

Interventions

Q/LAIV-BFS (MEDI8662)biological

A single dose of Q/LAIV-BFS delivered using the BFS delivery system (0.2 mL) on Day 0.

FluMist/B/Yamagatabiological

FluMist/B/Yamagata - 0.2 mL dose at Day 0

FluMist/B/Victoriabiological

FluMist/B/Victoria - 0.2 mL dose at Day 0