CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 300 enrolled
Drug / intervention
Bivalent influenza vaccine +1 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.

Search/NCT03564444
NCT03564444Phase 4Completed
CompareCT.gov

A Phase 4, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety of 2 New of 6:2 Influenza Virus Reassortants in Adults

MedImmune LLC·interventional·Posted Jun 20, 2018·Updated Dec 26, 2019

In Brief

A Phase 4 clinical trial evaluating Bivalent influenza vaccine and Placebo for Influenza and Healthy. Completed, enrolled 300 participants across 2 sites.

Detailed Summary

This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Healthy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 20, 2018
Enrollment StartJun 6, 2018
Primary CompletionDec 27, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.0 years ago

Interventions

Bivalent influenza vaccinebiological

A single dose of bivalent vaccine (10\^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.

Placeboother

A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.