At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 157 enrolled
Drug / intervention
Pandemic influenza vaccine GSK2340272Abiological
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.
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months
In Brief
A Phase 2 clinical trial evaluating Pandemic influenza vaccine GSK2340272A for Influenza. Completed, enrolled 157 participants across 5 sites.
Detailed Summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months. This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesSpain
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2009
Enrollment StartSep 2009
Primary CompletionNov 2010
TodayJul 2026
First PostedSep 3, 2009
Enrollment StartSep 10, 2009
Primary CompletionNov 24, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.8 years ago
Interventions
Pandemic influenza vaccine GSK2340272Abiological
Two primary intramuscular (IM) injections