At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 480 enrolled
Drug / intervention
Vaccine +1 morebiological
Likely dose
Vaccine 15 mcgfrom 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 3 Double Blinded, Randomized, Placebo- Controlled Study to Examine the Safety and Immunogenicity of a Seasonal Trivalent Split Inactivated Influenza Vaccine Produced by Institute Torlak in 18-65 Year Old Volunteers in Serbia
Institute of Virology, Vaccines and Sera, Torlak·interventional·Posted Oct 17, 2016·Updated Apr 19, 2019
In Brief
A Phase 3 clinical trial evaluating Vaccine and Placebo for Influenza. Completed, enrolled 480 participants across 6 sites.
Detailed Summary
A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesSerbia
CollaboratorsPATH, Comac Medical, World Health Organization
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartNov 2016
Primary CompletionJan 2017
Study CompletionMar 2017
TodayJul 2026
First PostedOct 17, 2016
Enrollment StartNov 28, 2016
Primary CompletionJan 8, 2017
Study CompletionMar 25, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 9.7 years ago
Interventions
Vaccinebiological
Seasonal trivalent split, inactivated influenza vaccine 15 mcg hemagglutinin antigen (HA) of each of A/H1N1; A/H3N2 and B strains; 0.5 mL by IM injection
Placeboother
Phosphate buffered saline, 0.5 mL by IM injection