At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 300 enrolled
Drug / intervention
Trivalent 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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults
In Brief
A Phase 4 clinical trial evaluating Trivalent Influenza Vaccine and Placebo for Influenza and Healthy. Completed, enrolled 300 participants across 3 sites.
Detailed Summary
This prospective annual release study is designed to evaluate the safety on new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2013-2014 influenza season.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2013
First PostedMay 2013
Primary CompletionDec 2013
TodayJul 2026
First PostedMay 21, 2013
Enrollment StartMay 1, 2013
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.1 years ago
Interventions
Trivalent Influenza Vaccinebiological
A single dose of 10\^(7.0 ± 0.5) FFU of trivalent influenza vaccine will be administered as intranasal spray on Day 1.
Placeboother
A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.