Clinical trial NCT05585632: A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old
Official title: Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or 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 Adults 50-75 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: SARS-CoV-2
Influenza
RSV
Keywords: mRNA-1230 Vaccine
mRNA-1045 Vaccine
SARS-CoV-2 Vaccine
Influenza Vaccine
RSV Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 392
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Investigator assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
* Body mass index of 18 to 35 kilograms/square meter (kg/m\^2) (inclusive) at the Screening Visit(s).
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.
* Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. The most recent COVID-19 vaccine (primary series or booster) must be ≥120 days before (or less per local guidance) Day 1.

Exclusion Criteria:

* Acutely ill or febrile (temperature ≥38.0°Celsius/\[100.4°Fahrenheit\]) 72 hours before or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window for re-evaluation and will retain their initially assigned participant number.
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months before screening (for corticosteroids ≥10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
* Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days before study injections (Day 1) or within 28 days after the study injection.
* Received a licensed seasonal influenza vaccine or any other investigational influenza or RSV vaccine within ≤180 days before Day 1.
* Tested positive for influenza or RSV by local health authority-approved testing methods within ≤180 days before Day 1.
* Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the United States Center for Disease Control (CDC) or the European Centre for Disease Prevention and Control as a high risk (close contact) of a COVID-19 case or known history of SARS-CoV-2 infection within the past 90 days before Day 1.
* Donated ≥450 mL of blood products within 28 days before the Screening Visit or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 8 (7 days post vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 29 (28 days post vaccination)
measure: Number of Participants with Medically-Attended AEs (MAAEs)
timeFrame: Day 1 through Day 361
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Day 1 through Day 361
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 361
measure: Number of Participants with AEs Leading to Discontinuation
timeFrame: Day 1 through Day 361
Secondary outcomes:
measure: Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29
timeFrame: Baseline (Day 1), Day 29
measure: Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
timeFrame: Baseline (Day 1) to Day 29
measure: SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)
timeFrame: Baseline (Day 1) to Day 29
measure: RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay
timeFrame: Baseline (Day 1) to Day 29
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America (cenexel)
state: Florida
city: Saint Petersburg
country: United States
facility: Accel Research Sites
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research - Family Medicine
state: Georgia
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Decatur
country: United States
facility: Cenexel IRA (iResearch Atlanta)
state: Georgia
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Southfield
country: United States
facility: DM Clinical Research
state: Michigan
city: Morehead City
country: United States
facility: Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates
state: North Carolina
city: Anderson
country: United States
facility: Velocity Clinical Research
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research
state: Texas
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Kanwal
state: New South Wales
city: Albion
country: Australia
facility: Paratus Clinical Research Brisbane
state: Queensland
city: Herston
country: Australia
facility: Nucleus Network Brisbane Clinic - Centre For Clinical Studies
state: Queensland
city: South Brisbane
country: Australia
facility: University of the Sunshine Coast
state: Queensland
city: Taringa
country: Australia
facility: AusTrials Taringa
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Newcastle
country: United Kingdom
facility: Newcastle University - Institute of Cellular Medicine (ICM)
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus
state: Nottinghamshire
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust - University of London - Th
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: