The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
392
Sterile liquid for injection
Sterile liquid for injection
Sterile liquid for injection
Formulation for injection
Formulation for injection
Accel Research Sites
DeLand, Florida, United States
Research Centers of America (cenexel)
Hollywood, Florida, United States
Accel Research Sites
St. Petersburg, Florida, United States
Atlanta Center for Medical Research - Family Medicine
Atlanta, Georgia, United States
Centricity Research
Columbus, Georgia, United States
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 8 (7 days post vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 29 (28 days post vaccination)
Number of Participants with Medically-Attended AEs (MAAEs)
Time frame: Day 1 through Day 361
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 through Day 361
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 361
Number of Participants with AEs Leading to Discontinuation
Time frame: Day 1 through Day 361
Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Time frame: Baseline (Day 1), Day 29
Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29
Time frame: Baseline (Day 1), Day 29
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
Time frame: Baseline (Day 1), Day 29
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Time frame: Baseline (Day 1), Day 29
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
Time frame: Baseline (Day 1), Day 29
Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29
Time frame: Baseline (Day 1), Day 29
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Time frame: Baseline (Day 1) to Day 29
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)
Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\*LLOQ if baseline titer is \<LLOQ in nAb titers measured by PsVNA (or binding antibody assay).
Time frame: Baseline (Day 1) to Day 29
RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay
Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥LLOQ or ≥4\*LLOQ if baseline titer is \<LLOQ in nAb titers measured by RSV neutralization assay.
Time frame: Baseline (Day 1) to Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cenexel IRA (iResearch Atlanta)
Decatur, Georgia, United States
Optimal Research
Peoria, Illinois, United States
DM Clinical Research
Southfield, Michigan, United States
Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)
Morehead City, North Carolina, United States
Trial Management Associates
Wilmington, North Carolina, United States
...and 20 more locations