At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,719 enrolled
Drug / intervention
MF59-eH1N1_fbiological
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 Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age
In Brief
A Phase 3 clinical trial evaluating MF59-eH1N1_f for Influenza. Completed, enrolled 2,719 participants across 21 sites in 2 countries.
Detailed Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesMexico, United States
CollaboratorsNovartis Vaccines
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionNov 2009
Study CompletionDec 2010
TodayJul 2026
First PostedSep 9, 2009
Enrollment StartSep 1, 2009
Primary CompletionNov 1, 2009
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago
Interventions
MF59-eH1N1_fbiological
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant