At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 240 enrolled
Drug / intervention
CSL425 +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 Phase II, Single-centre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's Monovalent H1N1 Influenza Virus Vaccine in Healthy Adults Aged 18 to < 65 Years.
In Brief
A Phase 2 clinical trial evaluating CSL425 for Influenza Caused by the Novel Influenza A (H1N1) Virus. Completed, enrolled 240 participants across 1 site.
Detailed Summary
The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2009
First PostedJul 2009
Primary CompletionSep 2009
Study CompletionMar 2010
TodayJul 2026
First PostedJul 14, 2009
Enrollment StartJul 1, 2009
Primary CompletionSep 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago
Interventions
CSL425biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)
CSL425biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume)