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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05585632
Other study ID # mRNA-1230-P101
Secondary ID 2022-002138-15
Status Completed
Phase Phase 1
First received
Last updated
Start date October 14, 2022
Est. completion date February 28, 2024

Study information

Verified date March 2024
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 392
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
mRNA-1010
Sterile liquid for injection
mRNA-1345
Sterile liquid for injection
mRNA-1273.214
Sterile liquid for injection
mRNA-1045
Formulation for injection
mRNA-1230
Formulation for injection

Locations

Country Name City State
Australia Paratus Clinical Research Brisbane Albion Queensland
Australia Paratus Clinical Research Western Sydney Blacktown New South Wales
Australia Emeritus Research Camberwell Victoria
Australia Nucleus Network Brisbane Clinic - Centre For Clinical Studies Herston Queensland
Australia Paratus Clinical Kanwal Kanwal New South Wales
Australia University of the Sunshine Coast South Brisbane Queensland
Australia AusTrials Taringa Taringa Queensland
United Kingdom Bristol Royal Hospital for Children Bristol
United Kingdom Royal Devon & Exeter Hospital Exeter
United Kingdom Chelsea and Westminster Hospital London
United Kingdom National Hospital for Neurology and Neurosurgery London
United Kingdom St George's Healthcare NHS Trust - University of London - Th London
United Kingdom Newcastle University - Institute of Cellular Medicine (ICM) Newcastle England
United Kingdom Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus Nottingham Nottinghamshire
United Kingdom University of Oxford Oxford Oxfordshire
United Kingdom Southampton General Hospital Southampton
United States Velocity Clinical Research Anderson South Carolina
United States Atlanta Center for Medical Research - Family Medicine Atlanta Georgia
United States Centricity Research Columbus Georgia
United States Cenexel IRA (iResearch Atlanta) Decatur Georgia
United States Accel Research Sites DeLand Florida
United States Research Centers of America (cenexel) Hollywood Florida
United States DM Clinical Research Houston Texas
United States Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) Morehead City North Carolina
United States Trial Management Associates Myrtle Beach South Carolina
United States Optimal Research Peoria Illinois
United States Accel Research Sites Saint Petersburg Florida
United States DM Clinical Research Southfield Michigan
United States DM Clinical Research Sugar Land Texas
United States Trial Management Associates Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Australia,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 8 (7 days post vaccination)
Primary Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 29 (28 days post vaccination)
Primary Number of Participants with Medically-Attended AEs (MAAEs) Day 1 through Day 361
Primary Number of Participants with Adverse Events of Special Interest (AESIs) Day 1 through Day 361
Primary Number of Participants with Serious Adverse Events (SAEs) Day 1 through Day 361
Primary Number of Participants with AEs Leading to Discontinuation Day 1 through Day 361
Secondary Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 Baseline (Day 1), Day 29
Secondary Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29 Baseline (Day 1), Day 29
Secondary Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29 Baseline (Day 1), Day 29
Secondary Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 Baseline (Day 1), Day 29
Secondary Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29 Baseline (Day 1), Day 29
Secondary Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29 Baseline (Day 1), Day 29
Secondary 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. Baseline (Day 1) to Day 29
Secondary 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 Baseline (Day 1) to Day 29
Secondary 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 Baseline (Day 1) to Day 29
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