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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

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ClinicalTrials.gov Identifier: NCT05585632
Recruitment Status : Recruiting
First Posted : October 19, 2022
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Influenza RSV Biological: mRNA-1010 Biological: mRNA-1345 Biological: mRNA-1273.214 Biological: mRNA-1045 Biological: mRNA-1230 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 675 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Prevention
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
Actual Study Start Date : October 14, 2022
Estimated Primary Completion Date : March 15, 2024
Estimated Study Completion Date : March 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1010
Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1.
 Biological: mRNA-1010
Sterile liquid for injection
Experimental: mRNA-1345
Participants will receive a dose of mRNA-1345 by IM injection on Day 1.
 Biological: mRNA-1345
Sterile liquid for injection
Experimental: mRNA-1273.214
Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1.
 Biological: mRNA-1273.214
Sterile liquid for injection
Experimental: mRNA-1045 Dose Level A
Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1.
 Biological: mRNA-1045
Formulation for injection
Experimental: mRNA-1045 Dose Level B
Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1.
 Biological: mRNA-1045
Formulation for injection
Experimental: mRNA-1045 Dose Level C
Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
 Biological: mRNA-1045
Formulation for injection
Experimental: mRNA-1230 Dose Level A
Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1.
 Biological: mRNA-1230
Formulation for injection
Experimental: mRNA-1230 Dose Level B
Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1.
 Biological: mRNA-1230
Formulation for injection
Experimental: mRNA-1230 Dose Level C
Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1.
 Biological: mRNA-1230
Formulation for injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days post vaccination) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 29 (28 days post vaccination) ]
  3. Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Day 1 through Day 361 ]
  4. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 through Day 361 ]
  5. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 361 ]
  6. Number of Participants with AEs Leading to Discontinuation [ Time Frame: Day 1 through Day 361 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29 [ Time Frame: Baseline (Day 1), Day 29 ]
  4. Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 [ Time Frame: Baseline (Day 1), Day 29 ]
  5. Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29 [ Time Frame: Baseline (Day 1), Day 29 ]
  6. Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29 [ Time Frame: Baseline (Day 1), Day 29 ]
  7. Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay [ Time Frame: Baseline (Day 1) to Day 29 ]
    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.

  8. SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay) [ Time Frame: Baseline (Day 1) to Day 29 ]
    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).

  9. RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay [ Time Frame: Baseline (Day 1) to Day 29 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05585632


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05585632    
Other Study ID Numbers: mRNA-1230-P101
2022-002138-15 ( EudraCT Number )
First Posted: October 19, 2022    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
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
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases