CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Monovalent influenza virus vaccine +1 morebiological
Likely dose
Monovalent influenza virus vaccine 0.5 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/NCT00873912
NCT00873912Phase 4Completed
CompareCT.gov

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of a New 6:2 Influenza Virus Reassortant in Healthy Adults

MedImmune LLC·interventional·Posted Apr 2, 2009·Updated Jul 14, 2011

In Brief

A Phase 4 clinical trial evaluating Monovalent influenza virus vaccine and Placebo for Healthy. Completed, enrolled 300 participants across 3 sites.

Detailed Summary

This prospective annual release study was designed to assess the safety of a monovalent influenza virus vaccine using a new strain recommended for the 2009-2010 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults received a single dose of vaccine or placebo and were followed for 180 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2009
Enrollment StartMay 1, 2009
Primary CompletionMay 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.3 years ago

Interventions

Monovalent influenza virus vaccinebiological

Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 FFU (fluorescent focus units) of the cold-adapted, attenuated, 6:2 reassortant influenza strain B/Brisbane/60/2008 (Victoria lineage).

Placebobiological

Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer.