NCT03390166

Immunogenicity and Safety of Tri Fluvac, a Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 945 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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

Detailed description

This is a phase II/III, non-inferiority double-blinded, randomized, controlled trial of 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). A total of about 945 healthy Thai male and female adult volunteers 18 through 49 years of age; 630 participants will be randomized to receive the GPO Tri Fluvac and 315 will receive an active comparator (a 2:1 ratio) (inclusion of \~7% lost to follow-up). Safety will be assessed for all participants through Day 90 after vaccination. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 586 individuals randomized to study vaccine and 293 active comparator vaccine recipients.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	GPO Tri Fluvac vaccine	The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
BIOLOGICAL	Licensed influenza vaccine	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.

Timeline

• Start date: 2017-07-24
• Primary completion: 2018-03-31
• Completion: 2019-02-12
• First posted: 2018-01-04
• Last updated: 2020-04-14
• Results posted: 2020-04-14

Locations

2 sites across 1 country: Thailand