Influenza Infection Clinical Trial
Official title:
A Phase 2, Double-blind, Randomized Controlled Study to Evaluate Immunogenicity and Safety of Intranasal Trivalent Influenza Virus Vaccine in Healthy Adult V Olunteers
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.
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.
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