A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

NCT05827926 | Completed Phase 1 Results FDA Drug

• 1 other identifier: mRNA-1083-P101
• Study Type: interventional
• Target: 1,758
• Locations: 1 country
• Sites: 69

Brief Summary

The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.

Conditions

SARS-CoV-2; Influenza

Keywords

mRNA-1083; mRNA-1083 Vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; Influenza Vaccine; Moderna; Influenza

Outcome Measures

Primary Outcomes (9)

• Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

  Solicited ARs (local and systemic) were reported by participants an electronic diary (eDiary). Local ARs included: injection site pain, injection site erythema (redness), injection site swelling/induration (hardness), and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs included: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills.

  Up to 7 days after study injection

• Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. Severity for all unsolicited AEs was determined by the Investigator based upon medical judgment and graded as Mild, Moderate or Severe. Number of participants with unsolicited AEs (SAEs and non-serious AEs) and severe AEs up to 28 days post-vaccination are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Up to 28 days after study injection

• Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Study Discontinuation

  An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs were protocol-defined medical concepts. An MAAE is an AE that lead to an unscheduled visit to an healthcare practitioner. This included visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site. Number of participants with SAEs, AESIs, MAAEs, and AEs leading to study discontinuation up to Day 181 are reported in this outcome measure. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 through Day 181

• Part 2: Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay

  Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the lower limit of quantification (LLOQ) were replaced by 0.5 \* LLOQ. Values greater than the upper limit of quantification (ULOQ) were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% confidence interval (CI) was calculated based on the t-distribution of the log-transformed values for geometric mean (GM) titer, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.

  Day 29

• Part 2: GM Concentration of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA)

  SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 arbitrary units (AU)/milliliter (mL) for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GM concentration, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.

  Day 29

• Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29, as Measured by HAI Assay

  Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Antibody values reported as below the LLOQ were replaced by 0.5 \* LLOQ. Values greater than the ULOQ were converted to the ULOQ. LLOQ = 10 and ULOQ = 3620 for Influenza A H1N1 antibody, LLOQ = 10 and ULOQ = 5120 for Influenza A H3N2 antibody, LLOQ = 10 and ULOQ = 1356 for Influenza B/Victoria-lineage antibody, and LLOQ = 10 and ULOQ = 1280 for Influenza B/Yamagata-lineage antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.

  Day 29

• Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29, as Measured by PsVNA

  SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Antibody values reported as below the LLOQ are replaced by 0.5 \* LLOQ. Values greater than the ULOQ are converted to the ULOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. 95% CI was calculated based on the t-distribution of the log-transformed values for GMFR values, then back transformed to the original scale for presentation. Arms based on the applicable vaccine for this Outcome Measure.

  Day 29

• Part 2: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay

  Influenza A strains included H1N1 and H3N2 and influenza B strains included Victoria-lineage and Yamagata-lineage. Seroconversion was defined as a pre-vaccination HAI titer \<1:10 and a post-vaccination HAI titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer. Arms based on the applicable vaccine for this Outcome Measure.

  Baseline to Day 29

• Part 2: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA

  SARS-CoV-2 strain included Omicron XBB.1.5 antibody. Seroresponse was defined as an increase from below the LLOQ to ≥4 \* LLOQ if Baseline neutralizing antibody (nAb) level was \< LLOQ, or ≥4-fold rise if Baseline nAb level was ≥ LLOQ. LLOQ = 38 and ULOQ = 6960 AU/mL for SARS-CoV-2 Omicron XBB.1.5 antibody. Arms based on the applicable vaccine for this Outcome Measure.

  Baseline to Day 29

Secondary Outcomes (12)

• Part 1: GMT of Antibodies for Influenza, as Measured by HAI Assay

  Baseline (Day 1), Day 29, and Day 181

• Part 1: GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA

  Baseline (Day 1), Day 29, and Day 181

• Part 1: GMFR of Antibodies for Influenza, as Measured by HAI Assay

  Day 29 and Day 181

• Part 1: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA

  Day 29 and Day 181

• Part 1: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay

  Baseline (Day 1) to Day 29, and Day 181

Study Arms (37)

Part 1 Cohort A2: mRNA-1083.1 Dose B

EXPERIMENTAL

Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.

Biological: mRNA-1083.1

Part 1 Cohort A3: mRNA-1083.1 Dose C

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.

Biological: mRNA-1083.1

Part 1 Cohort A4: mRNA-1083.2 Dose A

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.

Biological: mRNA-1083.2

Part 1 Cohort A5: mRNA-1083.2 Dose B

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.

Biological: mRNA-1083.2

Part 1 Cohort A6: mRNA-1083.2 Dose C

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.

Biological: mRNA-1083.2

Part 1 Cohort A7: mRNA-1083.3

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.3 on Day 1.

Biological: mRNA-1083.3

Part 1 Cohort A8: Investigational Influenza Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.

Biological: Investigational Influenza Vaccine 1

Part 1 Cohort A9: Investigational COVID-19 Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.

Biological: Investigational COVID-19 Vaccine 1

Part 1 Cohort A10: COVID-19 Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.

Biological: COVID-19 Vaccine 1

Part 1 Cohort A11: Investigational Influenza Vaccine 2

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.

Biological: Investigational Influenza Vaccine 2

Part 1 Cohort A12: Influenza Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.

Biological: Influenza Vaccine 1

Part 1 Cohort A13: Influenza Vaccine 2

ACTIVE COMPARATOR

Participants will receive single IM injection of Influenza Vaccine 2 on Day 1.

Biological: Influenza Vaccine 2

Part 1 Cohort B1: mRNA-1083.1 Dose A

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.

Biological: mRNA-1083.1

Part 1 Cohort B2: mRNA-1083.1 Dose B

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.

Biological: mRNA-1083.1

Part 1 Cohort B3: mRNA-1083.1 Dose C

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.

Biological: mRNA-1083.1

Part 1 Cohort B4: mRNA-1083.2 Dose A

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.

Biological: mRNA-1083.2

Part 1 Cohort B5: mRNA-1083.2 Dose B

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.

Biological: mRNA-1083.2

Part 1 Cohort B6: mRNA-1083.2 Dose C

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.

Biological: mRNA-1083.2

Part 1 Cohort B7: mRNA-1083.3

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083.3 on Day 1.

Biological: mRNA-1083.3

Part 1 Cohort B8: Investigational Influenza Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational Influenza Vaccine 1 on Day 1.

Biological: Investigational Influenza Vaccine 1

Part 1 Cohort B9: Investigational COVID-19 Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational COVID-19 Vaccine 1 on Day 1.

Biological: Investigational COVID-19 Vaccine 1

Part 1 Cohort B10: COVID-19 Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of COVID-19 Vaccine 1 on Day 1.

Biological: COVID-19 Vaccine 1

Part 1 Cohort B11: Investigational Influenza Vaccine 2

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational Influenza Vaccine 2 on Day 1.

Biological: Investigational Influenza Vaccine 2

Part 1 Cohort B12: Influenza Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.

Biological: Influenza Vaccine 1

Part 2: mRNA-1083 Composition 1 Dose A

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 2 Dose A

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 1 Dose B

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 2 Dose B

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 1 Dose C

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 2 Dose C

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level C on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 1 Dose D

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level D on Day 1.

Biological: mRNA-1083

Part 2: mRNA-1083 Composition 2 Dose D

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level D on Day 1.

Biological: mRNA-1083

Part 2: Investigational Influenza Vaccine 1 Dose A

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level A on Day 1.

Biological: Investigational Influenza Vaccine 1

Part 2: Investigational Influenza Vaccine 1 Dose B

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational Influenza Vaccine 1 at Dose Level B on Day 1.

Biological: Investigational Influenza Vaccine 1

Part 2: Investigational COVID-19 Vaccine 2

ACTIVE COMPARATOR

Participants will receive single IM injection of Investigational COVID-19 Vaccine 2 on Day 1.

Biological: Investigational COVID-19 Vaccine 2

Part 2: COVID-19 Vaccine 2

ACTIVE COMPARATOR

Participants will receive single IM injection of COVID-19 Vaccine 2 on Day 1.

Biological: COVID-19 Vaccine 2

Part 2: Influenza Vaccine 1

ACTIVE COMPARATOR

Participants will receive single IM injection of Influenza Vaccine 1 on Day 1.

Biological: Influenza Vaccine 1

Interventions

Influenza Vaccine 1 BIOLOGICAL

quadrivalent seasonal influenza vaccine

Part 1 Cohort A12: Influenza Vaccine 1; Part 1 Cohort B12: Influenza Vaccine 1; Part 2: Influenza Vaccine 1

mRNA-1083.1 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A2: mRNA-1083.1 Dose B; Part 1 Cohort A3: mRNA-1083.1 Dose C; Part 1 Cohort B1: mRNA-1083.1 Dose A; Part 1 Cohort B2: mRNA-1083.1 Dose B; Part 1 Cohort B3: mRNA-1083.1 Dose C

mRNA-1083.2 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A4: mRNA-1083.2 Dose A; Part 1 Cohort A5: mRNA-1083.2 Dose B; Part 1 Cohort A6: mRNA-1083.2 Dose C; Part 1 Cohort B4: mRNA-1083.2 Dose A; Part 1 Cohort B5: mRNA-1083.2 Dose B; Part 1 Cohort B6: mRNA-1083.2 Dose C

mRNA-1083.3 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A7: mRNA-1083.3; Part 1 Cohort B7: mRNA-1083.3

Investigational Influenza Vaccine 1 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A8: Investigational Influenza Vaccine 1; Part 1 Cohort B8: Investigational Influenza Vaccine 1; Part 2: Investigational Influenza Vaccine 1 Dose A; Part 2: Investigational Influenza Vaccine 1 Dose B

Investigational COVID-19 Vaccine 1 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A9: Investigational COVID-19 Vaccine 1; Part 1 Cohort B9: Investigational COVID-19 Vaccine 1

COVID-19 Vaccine 1 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A10: COVID-19 Vaccine 1; Part 1 Cohort B10: COVID-19 Vaccine 1

Investigational Influenza Vaccine 2 BIOLOGICAL

Sterile liquid for injection

Part 1 Cohort A11: Investigational Influenza Vaccine 2; Part 1 Cohort B11: Investigational Influenza Vaccine 2

Influenza Vaccine 2 BIOLOGICAL

quadrivalent seasonal influenza vaccine

Part 1 Cohort A13: Influenza Vaccine 2

mRNA-1083 BIOLOGICAL

Sterile liquid for injection

Part 2: mRNA-1083 Composition 1 Dose A; Part 2: mRNA-1083 Composition 1 Dose B; Part 2: mRNA-1083 Composition 1 Dose C; Part 2: mRNA-1083 Composition 1 Dose D; Part 2: mRNA-1083 Composition 2 Dose A; Part 2: mRNA-1083 Composition 2 Dose B; Part 2: mRNA-1083 Composition 2 Dose C; Part 2: mRNA-1083 Composition 2 Dose D

Investigational COVID-19 Vaccine 2 BIOLOGICAL

Sterile liquid for injection

Part 2: Investigational COVID-19 Vaccine 2

COVID-19 Vaccine 2 BIOLOGICAL

Sterile liquid for injection

Part 2: COVID-19 Vaccine 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Part 1 (Phase 1/2)
• Adults ≥18 to \<80 years of age at the time of consent.
• Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit.
• Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
• 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 through 90 days following vaccine administration, and not currently breastfeeding.
• 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 ≥120 days prior to Day 1.
• Part 2 (Phase 2 Extension)
• Adults ≥18 to \<50 years of age at the time of consent.
• BMI of 18 kg/m\^2 to 35 kg/m\^2 (inclusive) at the Screening Visit.
• Healthy as determined by medical evaluation, including medical history, and physical examination.
• 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 through 90 days following vaccine administration, and not currently breastfeeding.
• Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1.

You may not qualify if:

• Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension)
• 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 clinical trial or could interfere with the interpretation of study results.
• Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
• Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
• Participant 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.
• Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the clinical trial.
• Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home.
• Part 2 (Phase 2 Extension) Only
• Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (69)

Chandler Clinical Trials

Chandler, Arizona, 85224-6231, United States

Location

Benchmark Research

Colton, California, 92324, United States

Location

Marvel Clinical Research

Huntington Beach, California, 92647-6835, United States

Location

Central Valley Research

Modesto, California, 95350-5365, United States

Location

Benchmark Research

Sacramento, California, 95864-3102, United States

Location

Tekton Research

Longmont, Colorado, 80501-6461, United States

Location

Accel Research Sites

DeLand, Florida, 32720-0834, United States

Location

CenExel

Hollywood, Florida, 33024, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Jacksonville Center For Clinical Research

Jacksonville, Florida, 32216, United States

Location

Accel Research Sites

Maitland, Florida, 32751, United States

Location

Suncoast Research Group

Miami, Florida, 33135-1687, United States

Location

Centricity Research

Columbus, Georgia, 31904, United States

Location

Accel Research Site

Decatur, Georgia, 30030-2615, United States

Location

CenExel iResearch

Decatur, Georgia, 30030, United States

Location

Lifeline Primary Care

Lilburn, Georgia, 30047-2832, United States

Location

Koch Family Medicine

Morton, Illinois, 61550, United States

Location

Optimal Research

Peoria, Illinois, 61614-4885, United States

Location

DM Clinical Research

River Forest, Illinois, 60305-1876, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219-1389, United States

Location

Tekton Research

Wichita, Kansas, 67218-2913, United States

Location

Versailles Family Medicine

Versailles, Kentucky, 40383-1947, United States

Location

Velocity Clinical research

Baton Rouge, Louisiana, 70809, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

DelRicht Research

New Orleans, Louisiana, 70115, United States

Location

DelRicht Research

Prairieville, Louisiana, 70769, United States

Location

Annapolis Internal Medicine

Annapolis, Maryland, 21401, United States

Location

Velocity Clinical Research

Rockville, Maryland, 20854, United States

Location

DM Clinical Research

Brookline, Massachusetts, 02445-7113, United States

Location

Vida Clinical Studies

Dearborn Heights, Michigan, 48127-2234, United States

Location

DelRicht Research

Gulfport, Mississippi, 39503, United States

Location

Clay Platte Family Medicine

Kansas City, Missouri, 64151-2411, United States

Location

Velocity Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Excel Clinical Research

Las Vegas, Nevada, 89109-6209, United States

Location

CCT Research

Las Vegas, Nevada, 89119, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030-7193, United States

Location

Rochester Clinical Research

Rochester, New York, 14609-3169, United States

Location

Tryon Medical Partners

Charlotte, North Carolina, 28210, United States

Location

Trial Management Associates

Wilmington, North Carolina, 28403-6238, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45219, United States

Location

Velocity Clinical Research

Cincinnati, Ohio, 45246, United States

Location

Centricity Research

Columbus, Ohio, 43213, United States

Location

WellNow Urgent Care & Research

Dayton, Ohio, 45424-4019, United States

Location

Lynn Institute of East Oklahoma

Oklahoma City, Oklahoma, 73111-3324, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Tekton Research Inc

Yukon, Oklahoma, 73099-9518, United States

Location

DM Clinical Research

Philadelphia, Pennsylvania, 19107-1530, United States

Location

Mercado Medical Practice

Philadelphia, Pennsylvania, 19111-2432, United States

Location

DelRicht Research

Charleston, South Carolina, 29407, United States

Location

Trial Management Associates

Myrtle Beach, South Carolina, 29572-4612, United States

Location

Medical Care

Elizabethton, Tennessee, 37643, United States

Location

DelRicht Research

Hendersonville, Tennessee, 37075, United States

Location

Benchmark Research

Austin, Texas, 78705-3298, United States

Location

Tekton Research

Austin, Texas, 78745-1470, United States

Location

Tekton Research

Beaumont, Texas, 77706-3061, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Cyfair Clinical Research

Houston, Texas, 77065, United States

Location

Texas Center for Drug Development

Houston, Texas, 77081, United States

Location

DelRicht Research

McKinney, Texas, 75070, United States

Location

Benchmark Research

San Angelo, Texas, 76904-7610, United States

Location

Tekton Research

San Antonio, Texas, 78229, United States

Location

CCT Research

Pleasant View, Utah, 84404, United States

Location

Ogden Clinic

Roy, Utah, 84067, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Meridian Clinical Research

Hampton, Virginia, 23666, United States

Location

Velocity Clinical Research

Portsmouth, Virginia, 23703, United States

Location

Wenatchee Valley Hospital & Clinics Campus

Wenatchee, Washington, 98801, United States

Location

Related Publications (1)

• Rudman Spergel AK, Ananworanich J, Guo R, Deng W, Carmona L, Schaefers K, Paila YD, Kandinov B, Eger CH, Sinkiewicz M, Shao S, Henry C, Shaw CA. mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial. Nat Med. 2025 May;31(5):1484-1493. doi: 10.1038/s41591-025-03591-0. Epub 2025 Mar 18.

  PMID: 40102593 DERIVED

MeSH Terms

Conditions

Influenza, Human; Coronavirus Infections; Virus Diseases

Interventions

Baiya SARS-CoV-2 VAX COVID-19 vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; Coronaviridae Infections; Nidovirales Infections

Results Point of Contact

• Title: Moderna WeCare Team
• Organization: ModernaTX, Inc.

WeCareClinicalTrials@modernatx.com

+1-866-663-3762

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: April 25, 2023
• Study Start: April 14, 2023
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

US (69)