The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1273 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated variant vaccine or age group, a new subprotocol will be generated. Reported outcome measures are based upon master protocol. Not all reported outcome measures may be applicable to each subprotocol.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,144
Sterile liquid for injection
CenExel
Atlanta, Georgia, United States
RECRUITINGCenExel
Decatur, Georgia, United States
RECRUITINGVelocity Clinical Research
Baton Rouge, Louisiana, United States
mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants
Time frame: Up to Day 29
mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants
Time frame: Up to 28 days after last dose of study intervention
mRNA-1273.251 and mRNA-1273.261: Seroresponse Rate
Time frame: Up to Day 29
mRNA-1273.251: Geometric Mean Titer of Neutralizing Antibody Against COVID-19 Variants of Participants ≥12 to <65 Years Old and ≥65 Years Old
Time frame: Day 29
mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Withdrawal, and AEs of Special Interest
Time frame: Day 1 through end of study (up to Day 209)
mRNA-1273.251: Number of Participants with Solicited Local and Systemic Adverse Reactions
Time frame: Day 1 through 7 days after last dose of study intervention
mRNA-1273.251 and mRNA-1273.261: Number of Participants with Unsolicited AEs
Time frame: Day 1 through 28 days after last dose of study intervention
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Velocity Clinical Research
Gulfport, Mississippi, United States
RECRUITINGVelocity Clinical Research
Omaha, Nebraska, United States
RECRUITINGRichard Bennett - Clinical Research Partners
Richmond, Virginia, United States
RECRUITING