At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 60 enrolled
Drug / intervention
Trivalent Seasonal Influenza Vaccine +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.
A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study In Healthy Adult Volunteers In Vietnam To Examine The Safety And Immunogenicity Of A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced By IVAC
Institute of Vaccines and Medical Biologicals, Vietnam·interventional·Posted Nov 5, 2015·Updated Feb 15, 2019
In Brief
A Phase 1 clinical trial evaluating Trivalent Seasonal Influenza Vaccine and Placebo for Influenza, Human. Completed, enrolled 60 participants across 1 site.
Detailed Summary
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesVietnam
Timeline
Phase 1CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionFeb 2016
TodayJul 2026
First PostedNov 5, 2015
Enrollment StartNov 1, 2015
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.7 years ago
Interventions
Trivalent Seasonal Influenza Vaccinebiological
Placeboother
0.5 mL of phosphate buffered saline