NCT02894840

Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] will be given in both Phase I and Phase II of the study. The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days. Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	an inactivated influenza vaccine	The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
OTHER	Placebo	The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-07-01
• Completion: 2016-11-01
• First posted: 2016-09-09
• Last updated: 2020-03-17
• Results posted: 2018-09-19