At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 370 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, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
In Brief
A Phase 2 clinical trial evaluating CSL425 for Influenza Caused by the Novel Influenza A (H1N1) Virus. Completed, enrolled 370 participants across 5 sites.
Detailed Summary
The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartAug 2009
Primary CompletionOct 2009
Study CompletionApr 2010
TodayJul 2026
First PostedJul 15, 2009
Enrollment StartAug 1, 2009
Primary CompletionOct 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago
Interventions
CSL425biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
CSL425biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free