At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 6,104 enrolled
Drug / intervention
Trivalent split influenza vaccine (TIV) +2 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.
A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age
In Brief
A Phase 3 clinical trial evaluating Trivalent split influenza vaccine (TIV), MF59-adjuvanted trivalent influenza vaccine (aTIV), and 1 other intervention for Influenza Disease. Completed, enrolled 6,104 participants across 34 sites in 5 countries.
Detailed Summary
This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to \< 72 Months of Age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Disease
CountriesArgentina, Australia, Chile, Philippines, South Africa
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedMay 2011
Primary CompletionJul 2012
TodayJul 2026
First PostedMay 3, 2011
Enrollment StartApr 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.2 years ago
Interventions
Trivalent split influenza vaccine (TIV)biological
MF59-adjuvanted trivalent influenza vaccine (aTIV)biological
Licensed comparator trivalent split influenza vaccine (comparator TIV)biological