At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 205 enrolled
Drug / intervention
Inflexal V +1 morebiological
Likely dose
Inflexal V 0.25 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 III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule
In Brief
A Phase 3 clinical trial evaluating Inflexal V for Influenza. Completed, enrolled 205 participants across 2 sites.
Detailed Summary
The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - \<36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedOct 2010
Primary CompletionNov 2010
TodayJul 2026
First PostedOct 27, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 15.7 years ago
Interventions
Inflexal Vbiological
vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
Inflexal Vbiological
Inflexal V 0.5 mL administrated once only