CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,800 enrolled
Drug / intervention
Q/LAIV (MEDI3250) +2 morebiological
Likely dose
MEDI3250 (Q/LAIV) 0.2 mL single dose, Day 0AI-extracted
Key inclusion· 5
  • ✓Age 18 to 49 years inclusive at randomization
  • ✓Healthy by medical history and physical examination, OR presence of stable underlying chronic medical condition for which hospitalization was not required in the previous year
  • ✓Able to complete 180-day follow-up period post-vaccination
  • ✓Available by telephone for follow-up contact
Key exclusion· 12
  • ✕Acute illness or evidence of significant active infection at randomization
  • ✕Fever ≥100.4°F (38°C) at randomization
  • ✕History of asthma
  • ✕Immunosuppressive medications (corticosteroids ≥20 mg/day prednisone equivalent for ≥14 days within 30-day window)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00860067
NCT00860067Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age

MedImmune LLC·interventional·Posted Mar 11, 2009·Updated Dec 5, 2011

In Brief

A Phase 3 clinical trial evaluating Q/LAIV (MEDI3250), 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 objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2009
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.3 years ago

Interventions

Q/LAIV (MEDI3250)biological

0.2 mL dose at Day 0

FluMist/B/Yamagatabiological

0.2 mL dose at Day 0

FluMist/B/Victoriabiological

0.2 mL dose at Day 0