At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 200 enrolled
Drug / intervention
Trivalent influenza vaccine GSK 138842A +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.
Safety and Immunogenicity Study of GSK Biologicals' Cell Culture-based Influenza Virus Vaccine 1388442A Compared With US Licensed TIV in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Trivalent influenza vaccine GSK 138842A and Fluarix for Influenza. Completed, enrolled 200 participants across 2 sites.
Detailed Summary
The purpose of the study is to compare the safety of \& immune response to a single dose of GSK Biologicals' cell-culture based influenza vaccine 138842A with that of a US licensed, egg-based trivalent influenza vaccine \[Fluarix\] in healthy adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2008
First PostedJun 2008
Primary CompletionMar 2009
Study CompletionMar 2009
TodayJul 2026
First PostedJun 9, 2008
Enrollment StartJun 2, 2008
Primary CompletionMar 1, 2009
Study CompletionMar 26, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.1 years ago
Interventions
Trivalent influenza vaccine GSK 138842Abiological
IM injection on Day 0
Fluarixbiological
IM injection on Day 0