CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 340 enrolled
Drug / intervention
an inactivated 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.

Search/NCT02894840
NCT02894840Phase 2Completed
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A Phase I/II Randomized Double Blind Controlled Study to Evaluate the Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Split Virion Influenza Vaccine in Healthy Thai Adults Aged Between 18 Years to 49 Years

Mahidol University·interventional·Posted Sep 9, 2016·Updated Mar 17, 2020

In Brief

A Phase 2 clinical trial evaluating an inactivated influenza vaccine and Placebo for Influenza. Completed, enrolled 340 participants.

Detailed Summary

The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
Countries--
CollaboratorsThe Government Pharmaceutical Organization, World Health Organization

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 9, 2016
Enrollment StartNov 1, 2015
Primary CompletionJul 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.8 years ago

Interventions

an inactivated influenza vaccinebiological

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

Placeboother

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