NCT03784885

A Phase 2, Double-blind Study to Evaluate Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult

A Phase 2, Double-blind, Randomized Controlled Study to Evaluate Immunogenicity and Safety of Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult V Olunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 345 (actual)
• Sponsor: Advagene Biopharma Co. Ltd. · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The objectives of this phase 2 study are to evaluate immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in 2 doses in healthy adult volunteers.

Detailed description

This is a Phase 2 prospective, randomized controlled, double-blind, multi-center study to evaluate the immunogenicity, safety and tolerability of AD07030, a trivalent influenza virus antigens vaccine, given intranasally in healthy adult volunteers. About 358 healthy subjects, meeting all the eligibility criteria will be enrolled into the study and randomized into 3 study groups (in 2:2:1 ratio) to receive either the study vaccine at one of the dose levels of adjuvant AD07010 (30μg or 45μg LTh(αK)) in combination with hemagglutinin (HA) antigens or to receive control vaccine consisting of HA antigens alone. The 3 study groups are as follows: * Group 1: 22.5μg HA with 30μg AD07010 * Group 2: 22.5μg HA with 45μg AD07010 * Group 3: 22.5μg HA alone Each subject will receive intranasal administration of 2 doses of IP (study or control vaccine) at same dosages, given 7 days apart on study Day 1 and Day 8. Solicited local and general AEs will be recorded after each vaccination in the subject's diary card for up to 7 days (the vaccine administration day and 6 days following it). Subjects will be followed up for monitoring of safety and immunogenicity for 180 days. AE and SAE and concomitant medication/vaccination will be collected throughout the study. There will be total of 6 study visits and a telephone call.

Conditions

• Influenza Infection

Interventions

Type	Name	Description
BIOLOGICAL	AD07010	A protein based adjuvant
BIOLOGICAL	Inactivated trivalent influenza vaccine	Inactivated trivalent seasonal influenza vaccine

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-01-07
• Completion: 2018-10-30
• First posted: 2018-12-24
• Last updated: 2018-12-26

Locations

1 site across 1 country: Taiwan