CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 303 enrolled
Drug / intervention
Trivalent Influenza Virus Vaccine +1 morebiological
Likely dose
Trivalent 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/NCT01579916
NCT01579916Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

MedImmune LLC·interventional·Posted Apr 18, 2012·Updated Feb 3, 2014

In Brief

A Phase 4 clinical trial evaluating Trivalent Influenza Virus Vaccine and Placebo for Influenza. Completed, enrolled 303 participants across 3 sites.

Detailed Summary

This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 18, 2012
Enrollment StartMay 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 14.2 years ago

Interventions

Trivalent Influenza Virus Vaccinebiological

Trivalent vaccine is 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 each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.

Placeboother

Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.