Moderna Vaccine mRNA-1345 Observational Respiratory Syncytial Virus (RSV) Study

NCT05572658 | Completed

• 1 other identifier: mRNA-1345-P901
• Study Type: observational
• Target: 10,994
• Locations: 1 country
• Sites: 109

Brief Summary

The main goal of this observational study is to describe the health and economic outcomes associated with use of the Moderna mRNA-1345 vaccine.

Conditions

Respiratory Syncytial Virus

Keywords

Viral Diseases; Messenger RNA; Moderna; mRNA-1345; Effectiveness; Vaccines

Outcome Measures

Primary Outcomes (1)

• Rate of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

  From Day 15 up to 1 year

Secondary Outcomes (6)

• Length of Stay of Hospitalizations for Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

  From Day 15 up to 1 year

• Mean Total Cost of Hospitalizations and Mean Total Healthcare Cost Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

  From Day 15 up to 1 year

• Number of Participants with Use of Mechanical Ventilation, Supplemental Oxygen, and Intensive Care Unit Admissions During Hospitalizations Related to Cardiopulmonary, Cardiovascular, Respiratory, Pneumonia/Influenza, Pneumonia and Complications, or RSV

  From Day 15 up to 1 year

• Number of Participants with Antibiotic or Corticosteroid Treatment

  From Day 15 up to 1 year

• Number of Participants with Chronic Obstructive Pulmonary Disease (COPD), Congestive heart failure (CHF), and Asthma

  From Day 15 up to 1 year

Study Arms (2)

mRNA-1345: Exposed

Eligible US participants from the mRNA-1345-P301 (P301) study who received the mRNA-1345 vaccine.

Biological: mRNA-1345

Placebo/Control: Referent

Eligible US participants from the P301 study who received placebo.

Biological: Placebo

Interventions

mRNA-1345 BIOLOGICAL

Sterile liquid for injection

mRNA-1345: Exposed

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo/Control: Referent

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population of interest will include P301 participants randomized in the US who provide informed consent and meet eligibility criteria.

You may qualify if:

• Must be a participant in P301
• Must be based in the US
• Must provide informed consent for P901
• Adults who are primarily responsible for self-care and activities of daily living.
• Participants may have one or more chronic medical diagnoses (specifically chronic heart failure and chronic obstructive pulmonary disease) but should be medically stable in the opinion of the investigator.
• Body mass index from ≥18 kilograms (kg)/square meter (m\^2) to ≤35 kg/m\^2.

You may not qualify if:

• Receipt of any future licensed RSV vaccine at baseline.
• Receipt of any future licensed RSV vaccines during the study follow-up period will result in censorship on the date the vaccine was received.
• Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the Day 1 vaccination.
• Prior participation in research involving receipt of any investigational RSV product (drug/biologic/device).
• History of a serious reaction to any prior vaccination or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
• Received or plans to receive any non-study vaccine within 28 days before or after the Day 1 study injection. The exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of COVID-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the Day 1 study injection. Efforts should be made to space study injection and COVID-19 vaccination by at least 7 and preferably 14 days, but COVID-19 vaccination should not be delayed.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (109)

Accel Research Site - Achieve - Birmingham - ERN - PPDS

Birmingham, Alabama, 35209-6898, United States

Location

AES - DRS - Simon Williamson Clinic, PC - Birmingham

Birmingham, Alabama, 35211-1320, United States

Location

Lakeview Clinical Research

Guntersville, Alabama, 35976-2206, United States

Location

AES - DRS - Optimal Research Alabama - Huntsville

Huntsville, Alabama, 35802-2569, United States

Location

Desert Clinical Research, LLC

Mesa, Arizona, 85213-5226, United States

Location

Hope Research Institute LLC - Phoenix - Hunt - PPDS

Phoenix, Arizona, 85018-2657, United States

Location

AES - DRS - Phoenix Southeast - Chandler

Phoenix, Arizona, 85020-4327, United States

Location

AES - DRS - Central Phoenix Medical Clinic, LLC

Phoenix, Arizona, 85020-4348, United States

Location

Hope Research Institute LLC - Hunt - PPDS

Phoenix, Arizona, 85023, United States

Location

Hope Research Institute LLC - Hunt - PPDS

Tempe, Arizona, 85284-3499, United States

Location

Tucson Neuroscience Research - M3 WR

Tucson, Arizona, 85710-6152, United States

Location

Hope Clinical Research, LLC

Canoga Park, California, 91303-1844, United States

Location

Velocity Clinical Research - Chula Vista - ERN - PPDS

Chula Vista, California, 91911-6660, United States

Location

Paradigm Research

La Mesa, California, 91942-3189, United States

Location

Velocity Clinical Research - Chula Vista - PPDS

La Mesa, California, 91942-3189, United States

Location

PRI, LLC - Los Alamitos - M3 WR - ERN - PPDS

Los Alamitos, California, 90720-3589, United States

Location

PRI, LLC - Newport Beach - M3 WR - ERN - PPDS

Newport Beach, California, 92660, United States

Location

FOMAT Medical Research - FOMAT - HyperCore - PPDS

Oxnard, California, 93030-5841, United States

Location

Reddy Care Medical

Pomona, California, 91768-3027, United States

Location

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

Redding, California, 96001-0172, United States

Location

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

San Diego, California, 92108-5899, United States

Location

Lynn Institute of Denver - ERN - PPDS

Aurora, Colorado, 80012-4520, United States

Location

Tekton Research - Fort Collins - Platinum - PPDS

Fort Collins, Colorado, 80525, United States

Location

Tekton Research - Longmont - Platinum - PPDS

Longmont, Colorado, 80501-6461, United States

Location

Paradigm Clinical Research Institute Inc - ClinEdge - PPDS

Wheat Ridge, Colorado, 80033-6168, United States

Location

Velocity Clinical Research - New Smyrna Beach - ERN - PPDS

Edgewater, Florida, 32132-2720, United States

Location

Fleming Island Center For Clinical Research - ERN-PPDS

Fleming Island, Florida, 32003-4816, United States

Location

Velocity Clinical Research - Hallandale Beach - ERN - PPDS

Hallandale, Florida, 33009, United States

Location

Jacksonville Center For Clinical Research - ERN - PPDS

Jacksonville, Florida, 32216-4362, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Multi-Specialty Research Associates, Inc. M3 WR

Lake City, Florida, 32055, United States

Location

Accel Research Sites - Maitland - ERN - PPDS

Maitland, Florida, 32751-7258, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg

Pinellas Park, Florida, 33781-3228, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - The Villages

The Villages, Florida, 32162-7116, United States

Location

Palm Beach Research - ClinEdge - PPDS

West Palm Beach, Florida, 33409-3401, United States

Location

Clinical Site Partners - Winter Park - HyperCore - PPDS

Winter Park, Florida, 32789-4681, United States

Location

Masters of Clinical Research Inc.

Augusta, Georgia, 30909-1854, United States

Location

Centricity Research - Roswell - HyperCore - PPDS

Columbus, Georgia, 31904-5067, United States

Location

IResearch Atlanta LLC - ClinEdge - PPDS

Decatur, Georgia, 30030-3438, United States

Location

Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS

Fayetteville, Georgia, 30214-1578, United States

Location

Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS

Sandy Springs, Georgia, 30328-4277, United States

Location

Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta - ERN-PPDS

Stockbridge, Georgia, 30281-9054, United States

Location

Velocity Clinical Research - Boise - PPDS

Meridian, Idaho, 83642-6246, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - Chicago

Chicago, Illinois, 60654-4855, United States

Location

Affinity Health (Oak Brook)

Oak Brook, Illinois, 60523-4655, United States

Location

DM Clinical Research - Chicago - ERN - PPDS

River Forest, Illinois, 60305-1898, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - Evansville

Evansville, Indiana, 47714-8009, United States

Location

Velocity Clinical Research - Valparaiso - ERN - PPDS

Valparaiso, Indiana, 46383-2196, United States

Location

Versailles Family Medicine, PLLC

Versailles, Kentucky, 40383-1947, United States

Location

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

Baton Rouge, Louisiana, 70809-3416, United States

Location

Benchmark Research - Covington - HyperCore - PPDS

Covington, Louisiana, 70433, United States

Location

Benchmark Research - Metairie - HyperCore - PPDS

Metairie, Louisiana, 70006-5322, United States

Location

Clinical Trials of America, LLC

Monroe, Louisiana, 71201, United States

Location

DelRicht Clinical Research, LLC - Internal - Covington - PPDS

New Orleans, Louisiana, 70115, United States

Location

Javara Research Inc. - Annapolis - Javara - PPDS

Annapolis, Maryland, 21401, United States

Location

CBH Health - CenExcel CBH - PPDS

Gaithersburg, Maryland, 20877-1409, United States

Location

Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS

Rockville, Maryland, 20854-2957, United States

Location

Great Lakes Research Institute

Southfield, Michigan, 48075-5405, United States

Location

DM Clinical Research - Southfield - ERN - PPDS

Southfield, Michigan, 48076-5412, United States

Location

Clinical Research Institute, Inc - CRN - PPDS

Plymouth, Minnesota, 55441-2680, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis

Richfield, Minnesota, 55423-2590, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - St. Louis

St Louis, Missouri, 63141-7083, United States

Location

Montana Medical Research

Missoula, Montana, 59804, United States

Location

Skyline Medical Center, PC

Elkhorn, Nebraska, 68022-2889, United States

Location

Methodist Physicians Clinic - Prairie - CCT Research

Fremont, Nebraska, 68025-2592, United States

Location

Meridian Clinical Research (Grand Island) - Platinum - PPDS

Grand Island, Nebraska, 68803-3345, United States

Location

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

Omaha, Nebraska, 68114, United States

Location

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

Omaha, Nebraska, 68134-3664, United States

Location

CCT Research

Papillion, Nebraska, 68046, United States

Location

HEALOR Primary Care - Physicians Las Vegas

Las Vegas, Nevada, 89102, United States

Location

Excel Clinical Research - Las Vegas

Las Vegas, Nevada, 89109-6209, United States

Location

Velocity Clinical Research - East Syracuse - ERN - PPDS

East Syracuse, New York, 13057, United States

Location

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

Endwell, New York, 13760-3646, United States

Location

Meridian Clinical Research (Dakota Dunes-South Dakota) - Platinum - PPDS

Endwell, New York, 13760-3661, United States

Location

Drug Trials America

Hartsdale, New York, 10530-1911, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - New York

New York, New York, 10017-4008, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609-3173, United States

Location

Carolina Institute for Clinical Research - M3 WR - ERN - PPDS

Fayetteville, North Carolina, 28303-5537, United States

Location

Velocity Clinical Research - Cincinnati - ERN - PPDS

Blue Ash, Ohio, 45242-3762, United States

Location

Meridian Clinical Research - Cincinnati - Platinum - PPDS

Cincinnati, Ohio, 45219-2975, United States

Location

CTI Clinical Research Center - PPDS

Cincinnati, Ohio, 45227-2172, United States

Location

AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio, 45236-3669, United States

Location

Tekton Research - Oklahoma - Platinum - PPDS

Yukon, Oklahoma, 73099-6396, United States

Location

Tekton Research Inc.

Yukon, Oklahoma, 73099-9518, United States

Location

Hatboro Medical Associates PC

Hatboro, Pennsylvania, 19040-2045, United States

Location

DM Clinical Research - Philadelphia - ERN - PPDS

Philadelphia, Pennsylvania, 19107-1530, United States

Location

Tekton Research Inc.

Austin, Texas, 78745-1470, United States

Location

PanAmerican Clinical Research LLC

Brownsville, Texas, 78520-7256, United States

Location

Family Medicine Associates of Texas - Hunt - PPDS

Carrollton, Texas, 75010-4632, United States

Location

Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Javara - PPDS

Fort Worth, Texas, 76132, United States

Location

Allure Health LLC

Friendswood, Texas, 77546, United States

Location

Village Health Partners Frisco Medical Village

Frisco, Texas, 75033-4135, United States

Location

DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

Houston, Texas, 77081, United States

Location

DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS

Humble, Texas, 77338-4205, United States

Location

Ventavia Research Group - Platinum - PPDS

Keller, Texas, 76248-4235, United States

Location

AIM Trials

Plano, Texas, 75093-8346, United States

Location

Clinical Trials of Texas, Inc. - PPDS

San Antonio, Texas, 78229-3539, United States

Location

Javara, Inc./Texas Health Care, PLLC (d/b/a/ Privia Medical Group - North Texas) - Stephenville - Ja

Stephenville, Texas, 76401-1860, United States

Location

DM Clinical Research - Sugarland - ERN - PPDS

Sugar Land, Texas, 77478-4913, United States

Location

DM Clinical Research - ERN

Tomball, Texas, 77375-3332, United States

Location

DM Clinical Research - ERN - PPDS

Tomball, Texas, 77375-6543, United States

Location

Cope Family Medicine - Ogden Clinic - CCT

Bountiful, Utah, 84010-4862, United States

Location

Olympus Family Medicine - CCT Research

Holladay, Utah, 84117-7054, United States

Location

South Ogden Family Medicine/Ogden Clinic - CCT Research

South Ogden, Utah, 84405, United States

Location

Velocity Clinical Research - Banning - ERN - PPDS

West Jordan, Utah, 84088-8865, United States

Location

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

Portsmouth, Virginia, 23703-3200, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057-4927, United States

Location

Seattle Womens: Health, Research, Gynecology

Seattle, Washington, 98105-4028, United States

Location

MeSH Terms

Conditions

Virus Diseases

Interventions

mRNA-1345 respiratory syncytial virus vaccine

Condition Hierarchy (Ancestors)

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 10, 2022
• Study Start: September 15, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

US (109)