The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06097273
Recruitment Status : Active, not recruiting
First Posted : October 24, 2023
Last Update Posted : December 20, 2023
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to <65 years of age (Cohort B).

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Influenza Biological: mRNA-1083 Biological: Placebo Biological: Influenza Vaccine Biological: COVID-19 Vaccine Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8075 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Actual Study Start Date : October 19, 2023
Estimated Primary Completion Date : May 21, 2024
Estimated Study Completion Date : May 21, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Cohort A1: mRNA-1083 and Placebo
Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1.
 Biological: mRNA-1083
Suspension for injection

Biological: Placebo
0.9% sodium chloride suspension for injection
Active Comparator: Cohort A2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
 Biological: Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe])

Biological: COVID-19 Vaccine
Commercially available formulation (Suspension for injection)
Experimental: Cohort B1: mRNA-1083 and Placebo
Participants of age 50 to <65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1.
 Biological: mRNA-1083
Suspension for injection

Biological: Placebo
0.9% sodium chloride suspension for injection
Active Comparator: Cohort B2: Influenza Vaccine and COVID-19 Vaccine
Participants of age 50 to <65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
 Biological: Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe])

Biological: COVID-19 Vaccine
Commercially available formulation (Suspension for injection)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
  2. GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) [ Time Frame: Day 29 ]
  3. Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay [ Time Frame: Baseline to Day 29 ]
    Seroconversion is defined as a Day 29 post-injection level ≥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.

  4. SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA [ Time Frame: Baseline to Day 29 ]
    Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in neutralizing antibody (nAb) values measured by PsVNA.

  5. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to 7 days after study injection ]
  6. Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after study injection ]
  7. Number of Participants With Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through Day 181 ]
  8. Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 through Day 181 ]
  9. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 181 ]
  10. Number of Participants With AEs Leading to Discontinuation [ Time Frame: Day 1 through Day 181 ]

Secondary Outcome Measures :
  1. Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay [ Time Frame: Day 1, Day 29 ]
  2. GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA [ Time Frame: Day 1, Day 29 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Healthy adults either ≥65 years of age (Cohort A) or 50 to <65 years of age (Cohort B) at the time of consent (Screening Visit).
  • 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, and agreement to continue adequate contraception through 3 months following vaccine administration.
  • Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥90 days prior to Day 1.

Exclusion Criteria:

  • Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • 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.
  • Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
  • Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
  • Received a seasonal influenza vaccine ≤150 days prior to Day 1.
  • Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
  • Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
  • Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT06097273


Locations
Show Show 146 study locations
Sponsors and Collaborators
ModernaTX, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT06097273    
Other Study ID Numbers: mRNA-1083-P301
First Posted: October 24, 2023    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1083
mRNA-1083 Vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
 Virus Diseases
Messenger RNA
Influenza Vaccine
Moderna
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs