At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 301 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 Phase 4 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 301 participants across 3 sites.
Detailed Summary
This prospective annual release study is designed to evaluate the safety of 3 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2015-2016 influenza season
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartJun 2015
First PostedJun 2015
Primary CompletionJan 2016
TodayJul 2026
First PostedJun 16, 2015
Enrollment StartJun 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.0 years ago
Interventions
Trivalent Influenza Vaccinebiological
A single dose of 10\^(7.0 ± 0.5) FFU per strain 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.