A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
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ClinicalTrials.gov Identifier: NCT06097273 |
Recruitment Status :
Active, not recruiting
First Posted : October 24, 2023
Last Update Posted : December 20, 2023
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV-2 Influenza | Biological: mRNA-1083 Biological: Placebo Biological: Influenza Vaccine Biological: COVID-19 Vaccine | Phase 3 |
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 |
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.
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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.
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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.
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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.
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Biological: Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe]) Biological: COVID-19 Vaccine Commercially available formulation (Suspension for injection) |
- Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
- GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) [ Time Frame: Day 29 ]
- 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.
- 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.
- Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to 7 days after study injection ]
- Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to 28 days after study injection ]
- Number of Participants With Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through Day 181 ]
- Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 through Day 181 ]
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Day 1 through Day 181 ]
- Number of Participants With AEs Leading to Discontinuation [ Time Frame: Day 1 through Day 181 ]
- Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay [ Time Frame: Day 1, Day 29 ]
- GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA [ Time Frame: Day 1, Day 29 ]
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.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
mRNA-1083 mRNA-1083 Vaccine SARS-CoV-2 SARS-CoV-2 Vaccine Coronavirus |
Virus Diseases Messenger RNA Influenza Vaccine Moderna |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |