A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age

NCT05330975 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: mRNA-1345-P302
• Study Type: interventional
• Target: 3,317
• Locations: 1 country
• Sites: 62

Brief Summary

The main purposes of Part A of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with a seasonal influenza vaccine (Afluria® Quadrivalent); to evaluate the impact of coadministered influenza vaccine on the immune response to RSV-A; and to evaluate the impact of coadministered RSV vaccine on the immune response to influenza. The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.

Conditions

Respiratory Syncytial Virus

Keywords

Viral Diseases; Messenger RNA; Moderna; mRNA-1345; Respiratory syncytial virus; Safety; Vaccines; SARS-CoV-2

Outcome Measures

Primary Outcomes (20)

• Part A: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Within 7 Days After Day 1 Injection

  Solicited ARs were collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered adverse events (AEs). Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Within 7 days after Day 1 injection

• Part A: Number of Participants With Unsolicited Adverse Events (AEs) After Day 1 Injection

  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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 through Day 28 (28 days after Day 1 injection)

• Part A: Number of Participants With Medically Attended AEs (MAAEs), SAEs, Adverse Events of Special Interest (AESIs), and AEs Leading to Withdrawal

  A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 through Day 181 (end of Study Part A)

• Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) Neutralizing Antibodies (NAbs) at Day 29

  Antibody values reported as below lower limit of quantification (LLOQ) were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 international units (IU)/milliliter (mL) and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  Day 29

• Part A: Percentage of Participants With Seroresponse in RSV-A NAbs at Day 29

  Seroresponse was defined as ≥4 × lower limit of quantification (LLOQ) if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  Day 29

• Part A: GMT of Serum Anti-hemagglutination (HA) Ab Level, as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza at Day 29

  Influenza A strains included H1N1 and H3N2 and influenza B strains included Washington and Phuket strains. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 and ULOQ was 2560 for Influenza A. LLOQ was 10 and ULOQ was 640 for Influenza B. As prespecified, only arms where participants received Afluria® Quadrivalent are presented for this outcome measure.

  Day 29

• Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 1 Injection

  Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Within 7 days after Day 1 injection

• Part B: Number of Participants With Solicited Local and Systemic ARs Within 7 Days After Day 29 Injection

  Solicited ARs were collected in an eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Within 7 days after Day 29 injection

• Part B: Number of Participants With Unsolicited AEs After Day 1 Injection

  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 PT/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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 through Day 28 (28 days after Day 1 injection)

• Part B: Number of Participants With Unsolicited AEs After Day 29 Injection

  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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 29 through Day 57 (28 days after Day 29 injection)

• Part B: Number of Participants With MAAEs, SAEs, AESIs, and AEs Leading to Withdrawal

  A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. 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, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Day 1 through Day 211

• Part B: GMT of Serum RSV-A at Day 29

  Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the upper limit of quantification (ULOQ) were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  Day 29

• Part B: Percentage of Participants With Seroresponse for RSV-A Neutralizing Abs From Baseline to Day 29

  Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. As prespecified, only arms where participants received mRNA-1345 are presented for this outcome measure.

  Baseline to Day 29

• Part B: Geometric Mean Concentration (GMC) of Serum Ab Level, as Measured by Neutralization Assay for SARS-Cov-2 at Day 29

  The model-based GM titer was estimated on ANCOVA model. SARS-CoV-2 variants included Wuhan-Hu-1 and B.1.1.529. Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 10 arbitrary units (AU)/milliliters (mL) and ULOQ was 111433 AU/mL for Wuhan-Hu-1. LLOQ was 8 and ULOQ was B.1.1.529 for B1.1.529. As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.

  Day 29

• Part B: Percentage of Participants With Seroresponse for SARS-Cov-2 NAbs From Baseline to Day 29

  Seroresponse was defined as ≥4 × LLOQ if baseline was \<LLOQ or 4-fold or greater increase from baseline if baseline was ≥LLOQ. mRNA-As prespecified, only arms where participants received mRNA-1273.214 are presented for this outcome measure.

  Baseline to Day 29

• Part C: Number of Participants With Solicited Local and Systemic Within 7 Days After Revaccination Day 1

  Solicited ARs were collected in an electronic eDiary. Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to the side of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs were considered AEs. Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of SAEs and nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Within 7 days after Day 1 revaccination

• Part C: Number of Participants With Unsolicited AEs Within 28 Days After Revaccination Day 1

  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 PT/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. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Revaccination Day 1 through Day 28 (28 days after revaccination Day 1)

• Part C: Number of Participants With MAAEs

  A MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner.

  Revaccination Day 1 through Day 181

• Part C: Number of Participants With SAEs, AESIs, and AEs Leading to Withdrawal

  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, was a congenital anomaly/birth defect, or was an important medical event. An AESI is an AE (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor are required. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section.

  Revaccination Day 1 through Day 361

• Part C: GMT of Serum RSV-A and RSV-B NAbs mRNA-1345 Revaccination Day 29 Compared to Primary Vaccination Day 29

  Antibody values reported as below LLOQ were replaced by 0.5\*LLOQ. Values greater than the ULOQ were replaced by the ULOQ. LLOQ was 13 IU/mL and ULOQ was 259061 IU/mL for RSV-A. LLOQ was 10 IU/mL and ULOQ was 112476 IU/mL for RSV-B. mRNA-1345 Revaccination Day 29 and mRNA-1345 primary vaccination Day 29 (received in Part B) are presented.

  Primary Vaccination Day 29 to Revaccination Day 29

Secondary Outcomes (30)

• Part A: GMT of Serum RSV-B NAbs at Day 29

  Day 29

• Part A: Percentage of Participants With Seroresponse in RSV-B NAbs at Day 29

  Day 29

• Part A: Percentage of Participants With Seroconversion in Influenza A and B Strains at Day 181

  Day 181

• Part A: GMT of Serum RSV-A and RSV-B NAbs at Day 181

  Day 181

• Part A: Geometric Mean Fold Rise (GMFR) of Serum RSV-A and RSV-B NAbs at Day 181

  Day 181

Other Outcomes (1)

• Number of Deaths During the Study

  Up to Day 181 for Part A, up to Day 211 for Part B, and up to Day 361 for Part C

Study Arms (7)

Part A: mRNA-1345 + Placebo

EXPERIMENTAL

Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.

Biological: Placebo; Biological: mRNA-1345

Part A: mRNA-1345 + Afluria® Quadrivalent

EXPERIMENTAL

Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.

Biological: mRNA-1345; Biological: Afluria® Quadrivalent

Part A: Afluria® Quadrivalent + Placebo

ACTIVE COMPARATOR

Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.

Biological: Placebo; Biological: Afluria® Quadrivalent

Part B: mRNA-1345 + Placebo

EXPERIMENTAL

Single injection of mRNA-1345 and placebo, administered IM, one in each arm on Day 1. An additional injection of mRNA-1273.214, administered on Day 29.

Biological: Placebo; Biological: mRNA-1345; Biological: mRNA-1273.214

Part B: mRNA-1345 + mRNA-1273.214

EXPERIMENTAL

Single injection of mRNA-1345 and mRNA-1273.214, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.

Biological: Placebo; Biological: mRNA-1345; Biological: mRNA-1273.214

Part B: mRNA-1273.214 + Placebo

ACTIVE COMPARATOR

Single injection of mRNA-1273.214 and placebo, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.

Biological: Placebo; Biological: mRNA-1273.214

Part C: mRNA-1345

EXPERIMENTAL

Single injection of mRNA-1345 administered IM on BD Day 1.

Biological: mRNA-1345

Interventions

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Part A: Afluria® Quadrivalent + Placebo; Part A: mRNA-1345 + Placebo; Part B: mRNA-1273.214 + Placebo; Part B: mRNA-1345 + Placebo; Part B: mRNA-1345 + mRNA-1273.214

mRNA-1345 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1345 + Afluria® Quadrivalent; Part A: mRNA-1345 + Placebo; Part B: mRNA-1345 + Placebo; Part B: mRNA-1345 + mRNA-1273.214; Part C: mRNA-1345

Afluria® Quadrivalent BIOLOGICAL

single-dose, pre-filled syringe for injection

Part A: Afluria® Quadrivalent + Placebo; Part A: mRNA-1345 + Afluria® Quadrivalent

mRNA-1273.214 BIOLOGICAL

Sterile liquid for injection

Part B: mRNA-1273.214 + Placebo; Part B: mRNA-1345 + Placebo; Part B: mRNA-1345 + mRNA-1273.214

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parts A and B both:
• Adults ≥50 years of age on the day of the Randomization Visit (Day 1) who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: Absence of changes in medical therapy within 1 month due to treatment failure or toxicity; Absence of medical events qualifying as SAEs within 1 month of the planned vaccination on Day 1; and absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, would make completion of the protocol unlikely.
• Able to comply with study requirements, including access to transportation for study visits.
• Part B only:
• Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. If the most recent COVID-19 vaccine was part of a primary series, it must be ≥ 150 days before (or less per local guidance) Day 1. If the most recent COVID-19 vaccine was a booster dose, it must be ≥ 120 days before (or less per local guidance) Day 1.
• Part C:
• Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of this study; have immunogenicity blood sampling at Part B baseline and Day 29; completed the Day 211/end-of-study visits for Part B; were included in the per-protocol (PP) set; and received 1 dose of mRNA-1345 at least 12 months (but no later than 15 months) prior to the time of enrollment.
• Able to comply with study requirements, including access to transportation for study visits.

You may not qualify if:

• Part A:
• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
• Prior participation in research involving receipt of any investigational product (drug/biologic/device including any investigational RSV product) within 45 days before the planned date of the Day 1 study injection.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤180 days prior to the Randomization Visit (Day 1).
• History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
• Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
• Part B:
• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections (with the exception of SARS-Cov-2 vaccination).
• Prior participation in research involving receipt of any investigational product (drug/biologic/device with the exception of RSV investigation products) within 45 days before the planned date of the Day 1 study injection.
• Prior receipt of any investigational/approved RSV product within 1 year of the Day 1 study injection.
• Has known history of SARS-CoV-2 infection within 90 days prior to enrollment.
• Parts A and B both:
• Participant had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 10 days, as defined by the United States (US) Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.
• Part C:
• Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to the study injection (BD Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (62)

Central Research Associates Inc

Birmingham, Alabama, 35205, United States

Location

Del Sol Research Management - Clinedge - PPDS

Tucson, Arizona, 85715, United States

Location

Paragon Rx Clinical, Inc

Garden Grove, California, 92703-1811, United States

Location

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Long Beach Clinical Trials, LLC (Site 1)

Long Beach, California, 90806, United States

Location

Long Beach Clinical Trials, LLC (Site 2)

Long Beach, California, 90806, United States

Location

Central Valley Research, LLC

Modesto, California, 95350, United States

Location

Velocity Clinical Research - Panorama City

Panorama City, California, 91402-3022, United States

Location

Empire Clinical Research

Pomona, California, 91786, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Medical Center For Clinical Research - M3 WR - ERN - PPDS

San Diego, California, 92120, United States

Location

Ark Clinical Research

Tustin, California, 92780, United States

Location

Chase Medical Research LLC

Waterbury, Connecticut, 06708, United States

Location

Teradan Clinical Trials

Brandon, Florida, 33511-4925, United States

Location

Revival Research Corporation - Clinedge - PPDS

Doral, Florida, 33122, United States

Location

Dolphin Medical Research

Doral, Florida, 33172, United States

Location

Indago Research and Health Center

Hialeah, Florida, 33012, United States

Location

Westside Center for Clinical Research - ERN - PPDS

Jacksonville, Florida, 32205, United States

Location

Suncoast Research Group LLC - ERN-PPDS

Miami, Florida, 33135, United States

Location

Suncoast Research Associates LLC - ERN - PPDS

Miami, Florida, 33173, United States

Location

Floridian Clinical Research - ClinEdge - PPDS

Miami Lakes, Florida, 33016, United States

Location

Tekton Research - Georgia - Platinum - PPDS

Chamblee, Georgia, 30341, United States

Location

Lifeline Primary Care / CCT Research

Lilburn, Georgia, 30047-2832, United States

Location

Georgia Clinic / CCT Research

Norcross, Georgia, 30092-4544, United States

Location

Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS

Savannah, Georgia, 31406, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Meridian Clinical Research (Sioux City - Iowa)

Sioux City, Iowa, 51106, United States

Location

Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS

Overland Park, Kansas, 66210-1863, United States

Location

Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS

Baton Rouge, Louisiana, 70809, United States

Location

Clinical Trials of SWLA, LLC

Lake Charles, Louisiana, 70601, United States

Location

Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS

Rockville, Maryland, 20854-2957, United States

Location

Clinical Research Institute, Inc - CRN - PPDS

Minneapolis, Minnesota, 55402, United States

Location

Meridian Clinical Research (Grand Island) - Platinum - PPDS

Grand Island, Nebraska, 68803, United States

Location

Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS

Lincoln, Nebraska, 68510, United States

Location

Be Well Clinical Studies, LLC

Lincoln, Nebraska, 68516, United States

Location

Meridian Clinical Research

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS

Omaha, Nebraska, 68134, United States

Location

Midwest Regional Health Services - CCT Research

Omaha, Nebraska, 68144, United States

Location

Clinical Research Center of Nevada - ERN - PPDS

Las Vegas, Nevada, 89106, United States

Location

Santa Rosa Medical Centers of Nevada - CCT Research

Las Vegas, Nevada, 89119-5483, United States

Location

Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

Endwell, New York, 13760, United States

Location

IMA Medical Research, PC.

New York, New York, 10036-4103, United States

Location

CHEAR Center LLC - ClinEdge - PPDS

The Bronx, New York, 10455-3908, United States

Location

Javara Research Inc. - Charlotte - Javara - PPDS

Charlotte, North Carolina, 28210, United States

Location

M3 Wake Research, Inc - M3 WR - ERN - PPDS

Raleigh, North Carolina, 27612, United States

Location

Velocity Clinical Research - Cleveland - ERN - PPDS

Cleveland, Ohio, 44122, United States

Location

Meridian Clinical Research - Cincinnati - Platinum - PPDS

Springdale, Ohio, 45246, United States

Location

Tekton Research

Moore, Oklahoma, 73160-1386, United States

Location

Velocity Clinical Research - Anderson - ERN - PPDS

Anderson, South Carolina, 29621, United States

Location

Velocity Clinical Research - Greenville - ERN - PPDS

Greenville, South Carolina, 29615, United States

Location

Trial Management Associates LLC - ERN - PPDS

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

Location

Velocity Clinical Research - Spartanburg - ERN - PPDS

Spartanburg, South Carolina, 29303-4225, United States

Location

New Phase Research &amp; Development

Knoxville, Tennessee, 37909, United States

Location

Benchmark Research - Austin - HyperCore - PPDS

Austin, Texas, 78705, United States

Location

Tekton Research - Beaumont - Platinum - PPDS

Beaumont, Texas, 77706, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Milton Haber, M.D.

Laredo, Texas, 78041, United States

Location

Sun Research Institute

San Antonio, Texas, 78215-1922, United States

Location

Cope Family Medicine - Ogden Clinic

Bountiful, Utah, 84010-4862, United States

Location

CCT Research at Springville Dermatology

Springville, Utah, 84663, United States

Location

Javara Inc./Privia Medical Group INC

Forest, Virginia, 24551, United States

Location

Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS

Portsmouth, Virginia, 23703, United States

Location

Related Publications (2)

• Goswami J, Cardona JF, Caso J, Hsu DC, Simorellis AK, Wilson L, Dhar R, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Das R. Safety, Tolerability, and Immunogenicity of Revaccination with mRNA-1345, an mRNA Vaccine Against RSV, Administered 12 Months Following a Primary Dose in Adults Aged >/=50 Years. Clin Infect Dis. 2025 Sep 23:ciaf515. doi: 10.1093/cid/ciaf515. Online ahead of print.

  PMID: 40988124 DERIVED

• Goswami J, Cardona JF, Hsu DC, Simorellis AK, Wilson L, Dhar R, Tomassini JE, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Miller JM, Das R; study investigators. Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: an observer-blinded, placebo-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2025 Apr;25(4):411-423. doi: 10.1016/S1473-3099(24)00589-9. Epub 2024 Nov 25.

  PMID: 39608389 DERIVED

MeSH Terms

Conditions

Virus Diseases

Interventions

mRNA-1345 respiratory syncytial virus vaccine; mRNA-1273.214 COVID-19 vaccine

Condition Hierarchy (Ancestors)

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Parts A and B are randomized, observer blind studies and Part C is a single-arm, open-label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: April 1, 2022
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (62)