At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,654 enrolled
Drug / intervention
Cell culture-derived trivalent subunit influenza vaccine (cTIV) +1 morebiological
Likely dose
Cell culture-derived trivalent subunit influenza vaccine (cTIV) 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 III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects
In Brief
A Phase 3 clinical trial evaluating Cell culture-derived trivalent subunit influenza vaccine (cTIV) and Egg-derived trivalent subunit influenza vaccine (TIV) for Influenza. Completed, enrolled 2,654 participants across 5 sites.
Detailed Summary
The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesPoland
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
Primary CompletionDec 2004
Study CompletionMay 2005
First PostedJun 2007
TodayJul 2026
First PostedJun 27, 2007
Enrollment StartSep 1, 2004
Primary CompletionDec 1, 2004
Study CompletionMay 1, 2005
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 19.0 years ago
Interventions
Cell culture-derived trivalent subunit influenza vaccine (cTIV)biological
One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
Egg-derived trivalent subunit influenza vaccine (TIV)biological
One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle