At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 784 enrolled
Drug / intervention
MF59-eH1N1_f +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, Open Label, Single Center, Dose- and Regimen-Ranging 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 Children and Adults Ages 3 to 64 Years
In Brief
A Phase 3 clinical trial evaluating MF59-eH1N1_f and eH1N1_f for Novel 2009 Influenza H1N1. Completed, enrolled 784 participants across 1 site.
Detailed Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNovel 2009 Influenza H1N1
CountriesCosta Rica
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionOct 2009
Study CompletionOct 2010
TodayJul 2026
First PostedSep 9, 2009
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2009
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago
Interventions
MF59-eH1N1_fbiological
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
eH1N1_fbiological
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal