At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,357 enrolled
Drug / intervention
MF59-eH1N1biological
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 Pediatric Subjects 3 to < 9 Years of Age
In Brief
A Phase 3 clinical trial evaluating MF59-eH1N1 for Influenza. Completed, enrolled 1,357 participants across 35 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 healthy young children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesMexico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionNov 2009
Study CompletionOct 2010
TodayJul 2026
First PostedSep 9, 2009
Enrollment StartSep 1, 2009
Primary CompletionNov 1, 2009
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 16.8 years ago
Interventions
MF59-eH1N1biological
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).