At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 473 enrolled
Drug / intervention
CSL's 2009 H1N1 Influenza Vaccine (CSL425) +2 morebiological
Likely dose
CSL's 2009 H1N1 Influenza Vaccine (CSL425) 0.5 mLfrom 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, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population
In Brief
A Phase 2 clinical trial evaluating CSL's 2009 H1N1 Influenza Vaccine (CSL425) and Placebo for Influenza. Completed, enrolled 473 participants across 13 sites.
Detailed Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedAug 2009
Primary CompletionNov 2009
Study CompletionApr 2010
TodayJul 2026
First PostedAug 13, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.9 years ago
Interventions
CSL's 2009 H1N1 Influenza Vaccine (CSL425)biological
0.5 mL intramuscular injection on Day 0 and Day 21
CSL's 2009 H1N1 Influenza Vaccine (CSL425)biological
0.25 mL intramuscular injection on Day 0 and Day 21
Placebobiological
Placebo