The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
4,050
Sterile liquid for injection.
Sterile liquid for injection.
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43
HAI Titer \>=1:40.
Time frame: Day 43
Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay
Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.
Time frame: Day 43
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 50 (28 days after each injection)
Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 205
Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay
Time frame: Day 43
GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay
Time frame: Days 22 and 205
GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay
Time frame: Days 22 and 205
Percentage of Participants with HAI Titers at Different Cut-Offs
Cutoff included \>= 1:80.
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Velocity Clinical Research, San Bernardino
San Bernardino, California, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Velocity Clinical Research, Cleveland
Beachwood, Ohio, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, United States
Velocity Clinical Research, Dallas
Dallas, Texas, United States
Velocity Clinical Research, Suffolk
Suffolk, Virginia, United States
...and 25 more locations
Time frame: Up to Day 205