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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

Primary Purpose

SARS-CoV-2, Influenza, RSV

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
mRNA-1010
mRNA-1345
mRNA-1273.214
mRNA-1045
mRNA-1230
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 focused on measuring 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

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Accel Research Sites
  • Research Centers of America (cenexel)
  • Accel Research Sites
  • Atlanta Center for Medical Research - Family Medicine
  • Centricity Research
  • Cenexel IRA (iResearch Atlanta)
  • Optimal Research
  • DM Clinical Research
  • Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)
  • Trial Management Associates
  • Velocity Clinical Research
  • Trial Management Associates
  • DM Clinical Research
  • DM Clinical Research
  • Paratus Clinical Research Western Sydney
  • Paratus Clinical Kanwal
  • Paratus Clinical Research Brisbane
  • Nucleus Network Brisbane Clinic - Centre For Clinical Studies
  • University of the Sunshine Coast
  • AusTrials Taringa
  • Emeritus Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

mRNA-1010

mRNA-1345

mRNA-1273.214

mRNA-1045 Dose Level A

mRNA-1045 Dose Level B

mRNA-1045 Dose Level C

mRNA-1230 Dose Level A

mRNA-1230 Dose Level B

mRNA-1230 Dose Level C

Arm Description

Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Participants will receive a dose of mRNA-1345 by IM injection on Day 1.

Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.

Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.

Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.

Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.

Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.

Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.

Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Medically-Attended AEs (MAAEs)
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with AEs Leading to Discontinuation

Secondary Outcome Measures

Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29
Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
Change From Baseline in GMFR as Measured by Microneutralization Assay at 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.
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).
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.

Full Information

First Posted
October 14, 2022
Last Updated
April 4, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05585632
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All participants will be unblinded at Day 29 (1 month following study injection) to seek immunization with licensed influenza and/or SARS-CoV-2 vaccines, outside of the study, per local standard of care.
Allocation
Randomized
Enrollment
392 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1010
Arm Type
Experimental
Arm Description
Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
Arm Title
mRNA-1345
Arm Type
Experimental
Arm Description
Participants will receive a dose of mRNA-1345 by IM injection on Day 1.
Arm Title
mRNA-1273.214
Arm Type
Experimental
Arm Description
Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.
Arm Title
mRNA-1045 Dose Level A
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.
Arm Title
mRNA-1045 Dose Level B
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.
Arm Title
mRNA-1045 Dose Level C
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
Arm Title
mRNA-1230 Dose Level A
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.
Arm Title
mRNA-1230 Dose Level B
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.
Arm Title
mRNA-1230 Dose Level C
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.
Intervention Type
Biological
Intervention Name(s)
mRNA-1010
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1345
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1273.214
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1045
Intervention Description
Formulation for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1230
Intervention Description
Formulation for injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 8 (7 days post vaccination)
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 29 (28 days post vaccination)
Title
Number of Participants with Medically-Attended AEs (MAAEs)
Time Frame
Day 1 through Day 361
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame
Day 1 through Day 361
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Day 1 through Day 361
Title
Number of Participants with AEs Leading to Discontinuation
Time Frame
Day 1 through Day 361
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29
Time Frame
Baseline (Day 1), Day 29
Title
Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29
Time Frame
Baseline (Day 1), Day 29
Title
Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
Description
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
Title
SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay)
Description
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
Title
RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Accel Research Sites
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Centers of America (cenexel)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Accel Research Sites
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Atlanta Center for Medical Research - Family Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Centricity Research
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Cenexel IRA (iResearch Atlanta)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
DM Clinical Research
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC)
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Trial Management Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Velocity Clinical Research
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Trial Management Associates
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
DM Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
DM Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Paratus Clinical Research Western Sydney
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Paratus Clinical Kanwal
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Paratus Clinical Research Brisbane
City
Albion
State/Province
Queensland
ZIP/Postal Code
4010
Country
Australia
Facility Name
Nucleus Network Brisbane Clinic - Centre For Clinical Studies
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
University of the Sunshine Coast
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
AusTrials Taringa
City
Taringa
State/Province
Queensland
ZIP/Postal Code
QLD 4068
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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