At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 301 enrolled
Drug / intervention
Monovalent 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.
A Phase 4 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 1 New 6:2 Influenza Virus Reassortant in Adults
In Brief
A Phase 4 clinical trial evaluating Monovalent Influenza Vaccine and Placebo for Influenza and Healthy. Completed, enrolled 301 participants across 3 sites.
Detailed Summary
This prospective annual release study is designed to evaluate the safety of 1 new influenza virus vaccine strain to be included in FluMist Quadrivalent for the 2016-2017 influenza season
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionNov 2016
TodayJul 2026
First PostedApr 19, 2016
Enrollment StartMay 2, 2016
Primary CompletionNov 30, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.2 years ago
Interventions
Monovalent Influenza Vaccinebiological
A single dose of 10\^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.
Placeboother
A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.