At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 300 enrolled
Drug / intervention
Monovalent Frozen FluMist® +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 Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety of a New 6:2 Influenza Virus Reassortant
In Brief
A Phase 4 clinical trial evaluating Monovalent Frozen FluMist® and Placebo for Healthy. Completed, enrolled 300 participants across 3 sites.
Detailed Summary
To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionJun 2010
Study CompletionDec 2010
TodayJul 2026
First PostedApr 15, 2010
Enrollment StartMay 1, 2010
Primary CompletionJun 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.2 years ago
Interventions
Monovalent Frozen FluMist®biological
Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.
Placeboother
Single dose of placebo (60 subjects) by intranasal spray on Study Day 1