This study aims to evaluate the safety and reactogenicity profile of CVSQIV at different dose levels.
This is a Phase 1, open-label, dose-escalation FIH trial to evaluate the safety, reactogenicity and immunogenicity of different dose levels of CVSQIV using an adaptive dose-finding design.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Participants will receive an intramuscular injection by needle in the deltoid area.
International Vaccination and Research Center (CEVAXIN) Avenida Mexico, 33 Street
Panama City, Calidonia, Panama City, Panama
International Vaccination and Research Center (CEVAXIN) Panama Clinic, Ramon H Jurado Street, Pacific Center, Level 12
Panama City, Panama
Unidad de Investigación Clínica INDICASAT AIP / Hospital Paitilla
Panama City, Panama
The frequencies of Grade 3 ARs and any SAR within at least 20 hours after the trial vaccine administration by dose level, for decisions on subsequent vaccination of additional sentinel subjects with the same dose level.
Time frame: up to day 2
The frequencies of Grade 3 ARs and any SAR within at least 60 hours after the trial vaccine administration by dose level, for decisions on dose escalation as well as continuation of enrollment at the same dose level.
Time frame: up to day 3
The frequencies, intensities and duration of solicited local ARs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
Time frame: up to day 8
The frequencies, intensities, duration and relationship to trial vaccination of solicited systemic AEs on the day of vaccination and the following 7 days by dose level, for the characterization of the safety and reactogenicity profile.
Time frame: up to day 8
The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on the day of vaccination and the following 28 days by dose level, for the characterization of the safety and reactogenicity profile.
Time frame: up to day 29
The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial, for the characterization of the safety and reactogenicity profile.
Time frame: through study completion, an average of 6 months
For each antigen, the proportion of subjects with antigen-specific serum HAI assay titers.
Time frame: On Day 22 and Day 183
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For each antigen, geometric mean titers (GMTs) of antigen-specific HAI antibody titers.
Time frame: On Day 22 and Day 183
For each antigen, the proportion of subjects with antigen-specific seroconversion measured by HAI assay.
Time frame: On Day 22 and Day 183
For each antigen, the percentage of subjects with a post-vaccination HAI antibody titer ≥1:20, ≥1:40 and ≥1:80.
Time frame: On Day 22 and Day 183