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

Influenza Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• RSV
• SARS-CoV-2

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