CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 945 enrolled
Drug / intervention
GPO Tri Fluvac 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.

Search/NCT03390166
NCT03390166Phase 3Completed

A Phase II/III Double Blinded, Randomized, Controlled, Non-inferiority Trial to Evaluate the Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine, in Healthy Thai Subjects Aged 18-49 Years

Mahidol University·interventional·Posted Jan 4, 2018·Updated Apr 14, 2020

In Brief

A Phase 3 clinical trial evaluating GPO Tri Fluvac vaccine and Licensed influenza vaccine for Influenza. Completed, enrolled 945 participants across 2 sites.

Detailed Summary

The study is aim to evaluate the immunogenicity and safety with two groups of participants who will received a seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or an active comparator (licensed influenza vaccine

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesThailand

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartJul 24, 2017
Primary CompletionMar 31, 2018
Study CompletionFeb 12, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.5 years ago

Interventions

GPO Tri Fluvac vaccinebiological

The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Licensed influenza vaccinebiological

The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.