Influenza, SARS-CoV-2
Conditions
Keywords
Influenza, SARS-CoV-2, mRNA-1083, COVID-19, Messenger RNA, Moderna
Brief summary
The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.
Interventions
BIOLOGICALmRNA-1083 Composition 1 Dose A Lot A
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 1 Dose A Lot B
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 1 Dose B
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 1 Dose C
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 2 Dose A
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 2 Dose B
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 3 Dose A
Sterile liquid for injection
BIOLOGICALmRNA-1083 Composition 3 Dose B
Sterile liquid for injection
BIOLOGICALInfluenza Vaccine
Sterile liquid for injection
BIOLOGICALCOVID-19 Vaccine
Sterile liquid for injection
BIOLOGICALInvestigational Influenza Vaccine
Sterile liquid for injection
BIOLOGICALInvestigational COVID-19 Vaccine Lot A
Sterile liquid for injection
BIOLOGICALInvestigational COVID-19 Vaccine Lot B
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Medically stable. * Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration. * Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1.
Exclusion criteria
* History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures. * Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1. * History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1. * Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study. * Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection. * Received a licensed seasonal influenza vaccine within 150 days prior to Day 1. * Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1. * Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. * Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline). Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study | Day 1 through Day 181 |
| Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza | Day 29 |
| Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | Day 29 |
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Day 1 through 7 days after study injection |
| Number of Participants With Unsolicited Adverse Events (AEs) | Day 1 through 28 days after study injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA | Baseline (Day 1), Day 29 | — |
| Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay | Baseline (Day 1) to Day 29 | Seroconversion is defined as postinjection level ≥1:40 if baseline is \<1:10 or at least a 4-fold rise if baseline is ≥1:10 in HAI antibody titer. |
| SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA | Baseline (Day 1) to Day 29 | Seroresponse is defined as PsVNA concentration change from preinjection baseline below the lower limit of quantification (LLOQ) to postinjection ≥4×LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ. |
| Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay | Baseline (Day 1), Day 29 | — |
Countries
United States
Outcome results
None listed