The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participant will be approximately 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
276
Pharmaceutical Form: Suspension for injection Route of Administration: Intramuscular (IM)
Pharmaceutical Form: Liquid solution for injection Route of Administration: Intramuscular (IM)
Velocity Clinical Research - San Diego- Site Number : 8400013
La Mesa, California, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002
DeLand, Florida, United States
Presence of immediate adverse events (AEs) within 30 minutes after each/any injection
Number of participants experiencing immediate AEs
Time frame: Within 30 minutes of any/each injections
Presence of solicited injection site reactions through 7 days after each/any injection
Number of participants experiencing solicited injection site reactions
Time frame: Through 7 days after each/any injections
Presence of solicited systemic site reactions through 7 days after each/any injection
Number of participants experiencing solicited systemic site reactions
Time frame: Through 7 days after each/any injections
Presence of unsolicited AEs through 21 days after the first injection and through 28 days after the second injection
Number of participants experiencing unsolicited AEs
Time frame: Through 21 days after the first injection and through 28 days after the second injection
Presence of medically attended adverse events (MAAEs) through 180 days after the last injection
Number of participants experiencing MAAEs
Time frame: Through 180 days after the last injection
Presence of adverse events of special interest (AESIs) throughout the study
Number of participants experiencing AESIs
Time frame: Throughout the study, approximately 13 months
Presence of serious adverse events (SAEs) throughout the study
Number of participants experiencing SAEs
Time frame: Throughout the study, approximately 13 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ARSN-Lakeland CRU- Site Number : 8400006
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg- Site Number : 8400004
Largo, Florida, United States
Atlanta Clinical Research Center- Site Number : 8400007
Atlanta, Georgia, United States
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003
Decatur, Georgia, United States
QUEST Research Institute- Site Number : 8400014
Bingham Farms, Michigan, United States
Velocity Clinical Research - Norfolk- Site Number : 8400015
Norfolk, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400012
Omaha, Nebraska, United States
Velocity Clinical Research - Springdale- Site Number : 8400010
Cincinnati, Ohio, United States
...and 4 more locations
Presence of out-of-range biological test results (including shift from baseline values) through a maximum of 8 days after each injection
Number of participants with out-of-range biological test results
Time frame: Through a maximum of 8 days after each injection
Antibody titers measured by Hemagglutination Inhibition (HAI) Assay
Antibody titers are expressed as geometric mean titers (GMTs)
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
Individual HAI titer ratio
Time frame: At Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01
≥ 4-fold increase in HAI titer [1/dilution])
Time frame: At Day 22 or Day 43
HAI titer ≥ 10 [1/dilution]
Time frame: At day 01
HAI titer ≥ 40 [1/dilution]
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
Detectable HAI titer ≥ 10 [1/dilution]
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
Antibody titers measured by Seroneutralization (SN) test
Antibody titers are expressed as GMTs
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
Individual SN titer ratio
Time frame: Day 22/Day 01, Day 43/Day 01, Day 112/Day 01, and Day 202/Day 01
SN titer ≥ 20 (1/dilution)
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
SN titer ≥ 40 (1/dilution)
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
SN titer ≥ 80 (1/dilution)
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
Detectable SN titer ≥ 10 (1/dilution)
Time frame: At Day 01, Day 22, Day 43, Day 112, and Day 202
2-fold rise in SN titer
Time frame: At Day 22 and Day 43
4-fold rise in SN titer
Time frame: At Day 22 and Day 43