At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 300 enrolled
Drug / intervention
MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] +1 morebiological
Likely dose
MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] 0.5 mLfrom 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 MEDI3414 in Adults
In Brief
A Phase 4 clinical trial evaluating MEDI3414 [Influenza A/H1N1 live attenuated, intranasal] and Placebo for Healthy. Completed, enrolled 300 participants across 5 sites.
Detailed Summary
The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionSep 2009
Study CompletionMar 2010
TodayJul 2026
First PostedJul 24, 2009
Enrollment StartAug 1, 2009
Primary CompletionSep 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago
Interventions
MEDI3414 [Influenza A/H1N1 live attenuated, intranasal]biological
0.5 mL; (intranasal sprayer)
Placeboother
(intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer)