A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Respiratory Syncytial Virus Clinical Trial

Official title:

A Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus (RSV), in Adults ≥60 Years of Age

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05127434
• Other study ID #: mRNA-1345-P301
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 17, 2021
• Est. completion date: August 25, 2025

Study information

• Verified date: February 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

Description:

The study will be conducted in 2 phases: Phase 2 and Phase 3. In the Part A Phase 2 segment, up to 2,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio. In the Part A Phase 3 segment, approximately 35,000 participants will be randomly assigned to receive a single injection of either mRNA-1345 vaccine at the selected dose or placebo in a 1:1 randomization ratio. In the Part B substudy, 1500 participants who received a dose of mRNA-1345 in Part A Phase 3 will be randomly assigned in a 2:1 randomization ratio to receive a single BD injection of either mRNA-1345 at the selected dose or placebo.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36557
• Est. completion date: August 25, 2025
• Est. primary completion date: August 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Key Inclusion Criteria (Part A):

• Adults = 60 years of age who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses (including chronic heart failure [CHF] and chronic obstructive pulmonary disease [COPD]), but should be medically stable
• Body mass index from =18 kilograms (kg)/square meter (m^2) to =35 kg/m^2

Key Inclusion Criteria (Part B):

• Randomized to and were subsequently vaccinated with the mRNA-1345 study injection in Part A at least 21 months prior to Screening.

Key Exclusion Criteria (Part A):

• Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the Day 1 study injection.
• Current participation in research involving receipt of any investigational RSV product
• 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.

Key Exclusion Criteria (Part B):

• Participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of BD study injection (BD Day 1).
• 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 (including authorized or approved vaccines for the prevention of coronavirus disease 2019 (COVID-19) regardless of type of vaccine) within 14 days before or after the BD Day 1 study injection.
• Received or plans to receive any commercial RSV vaccination at any time prior to BD study injection (BD Day 1) or during the substudy. Other inclusion and/or exclusion criteria may apply.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus
• Virus Diseases

Intervention

Drug:
• Placebo
0.9% sodium chloride (normal saline) injection
• mRNA-1345
Sterile liquid for injection

Locations

Country	Name	City	State
Argentina	Instituto Medico Platense	Buenos Aires	Provincial De Buenos Aires
Argentina	Centro Medico Barrio Parque	Ciudad Autónoma de BuenosAires
Argentina	Consultorios Médicos Dr. Doreski	Ciudad Autónoma de BuenosAires
Argentina	Fundación Dr. Mario Socolinsky - Centro de Vacunación Proteger	Ciudad Autónoma de BuenosAires
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Ciudad Autónoma de BuenosAires
Australia	Paratus Clinical Research - Western Sydney - PPDS	Blacktown	New South Wales
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Paratus Clinical Research - Canberra - PPDS	Bruce	Australian Capital Territory
Australia	Emeritus Research - PPDS	Camberwell	Victoria
Australia	Northside Health	Coffs Harbour	New South Wales
Australia	Holdsworth House Medical Brisbane	Fortitude Valley	Queensland
Bangladesh	icddr,b Matlab Health Research Center	Chandpur
Bangladesh	Icddr,b Kamalapur Field Site	Dhaka
Bangladesh	JHU-Projahnmo Sylhet site	Sylhet
Bangladesh	JHU-Projahnmo Zakiganj site	Zakiganj	Sylhet
Belgium	ANIMA Research Center	Diepenbeek
Belgium	Vaccinopolis	Edegem
Belgium	Private Practice Dr Jean Benoit Martinot	Erpent
Belgium	Ziekenhuis Oost-Limburg	Genk
Canada	Centricity Research - Toronto - HyperCore - PPDS	Etobicoke	Ontario
Canada	Dr. Steven Z. Zizzo Medicine Professional Corporation	Hamilton	Ontario
Canada	Okanagan Clinical Trials - Headlands - PPDS	Kelowna	British Columbia
Canada	Centricity Research - Quebec - HyperCore - PPDS	Levis	Quebec
Canada	Diex Recherche - Québec - PPDS	Québec
Canada	CARe Clinic	Red Deer	Alberta
Canada	Diex Recherche - Sherbrooke - PPDS	Sherbrooke	Quebec
Canada	Diex Recherche - Joilette - PPDS	St-Charles-Borromee	Quebec
Canada	LMC Clinical Research Inc (Bayview)	Toronto	Ontario
Canada	Diex Recherche - Trois Rivieres - PPDS	Trois-Rivieres	Quebec
Chile	Hospital Base de Osorno	Osorno	Region De Los Lagos
Chile	Centro Respiratorio Integral LTDA. (CENRESIN)	Quillota	Region De Valparaiso
Chile	BIOCINETIC SpA	Santiago	Region Metropolitana
Chile	Biomedica Research Group	Santiago	Region Metropolitana
Chile	Centro de Investigacion del Maule	Talca	Region Del Maule
Colombia	Centro de Atención e Investigación Médica S.A. - CAIMED - Aguazul	Aguazul	Casanare
Colombia	Institucion Clinica de la Costa SAS	Barranquilla	Atlantico
Colombia	Centro de Atención e Investigación Médica S.A. - CAIMED - Bogota	Bogota	Cundinamarca
Colombia	Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogota	Bogota	Cundinamarca
Colombia	Centro Medico Imbanaco de Cali S.A.	Cali	Valle De Cuaca
Colombia	Centro de Atención e Investigación Médica S.A. - CAIMED - Chia	Chia	Cundinamarca
Colombia	Fundacion Oftalmologica de Santander Foscal	Floridablanca	Santandar
Colombia	Centro de Atención e Investigación Médica S.A. - CAIMED - Girardot	Girardot	Cundinamarca
Colombia	Centro de Atención e Investigación Médica S.A. - CAIMED - Ibague	Ibague	Tolima
Colombia	IPS Centro de Investigacion Clinicas Cardiomet	Pereira	Risaralda
Costa Rica	Campus Universidad EARTH, finca La Flor	Liberia	Guanacaste
Costa Rica	Hospital CIMA San Jose	San José
Costa Rica	Hospital Clínica Bíblica Sede Santa Ana	San José
Costa Rica	Instituto de Investigación en Ciencias Médicas S.A.	San José
Finland	Espoo Vaccine Research Clinic	Espoo
Finland	Helsinki East Vaccine Research Clinic	Helsinki
Finland	Helsinki South Vaccine Research Clinic	Helsinki
Finland	Järvenpää Vaccine Research Clinic	Järvenpää
Finland	KokkolaVaccine Research Clinic	Kokkola
Finland	Oulu Vaccine Research Clinic	Oulu
Finland	Pori Vaccine Research Clinic	Pori
Finland	Seinäjoki Vaccine Research Clinic	Seinäjoki
Finland	Tampere Vaccine Research Clinic	Tampere
Finland	Turku Vaccine Research Clinic	Turku
Germany	AES - DRS - Synexus Berlin Research Centre	Berlin
Germany	Medizentrum Essen Borbeck	Essen	North Rhine-Westphalia
Germany	AES - DRS - Synexus Frankfurt Research Centre	Frankfurt	Hesse
Germany	Infektioresearch GmbH & Co. KG	Frankfurt	Hesse
Germany	Klinische Forschung Hannover-Mitte GmbH	Hannover	Lower Saxony
Germany	Klinische Forschung, Schwerin GmbH (KFGN)	Schwerin	Mecklenburg-West Pomerania
Japan	Medical Corporation Asbo Tokyo Asbo Clinic	Chuo-ku	Tokyo
Japan	Fukui General Clinic	Fukui-shi	Fukui
Japan	SOUSEIKAI PS Clinic	Fukuoka
Japan	Tenjin Sogo Clinic	Fukuoka-shi	Fukuoka
Japan	Boocs Clinic Fukuoka	Hakata-ku	Fukuoka
Japan	Motomachi Takatsuka Naika Clinic	Naka-ku, Yokohama-ku	Kanagawa
Japan	Center Hospital of the National Center for Global Health and Medicine	Shinjuku-ku	Tokyo
Japan	Higashi Shinjuku Clinic	Shinjuku-ku	Tokyo
Japan	NewHeart Watanabe Institute	Suginami-ku	Tokyo
Japan	Sekino Hospital	Toshima-ku	Tokyo
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Samsung Medical Center - PPDS	Gangnam-gu	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Gangseo-gu	Seoul
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Gyeonggi-do
Korea, Republic of	Catholic Kwandong University International St. Mar	Incheon
Korea, Republic of	Inha University Hospital	Jung-gu	Incheon
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju-si	Gangwon-do
Mexico	Investigacion en Salud y Metabolismo S.C.	Chihuahua
Mexico	AES - AS - CEMDEC Mexico City	Ciudad De Mexcio
Mexico	AES - AS - RM Pharma Specialists Mexico City	Ciudad De Mexcio
Mexico	Hospital General 450	Durango
Mexico	Maria del rayo morfin otero	Guadalajara	Jalisco
Mexico	Accelerium, S. de R.L. de C.V.	Monterrey	Nuevo Leon
Mexico	PanAmerican Clinical Research-Avenida	Querétaro
New Zealand	New Zealand Clinical Research - Auckland	Auckland
New Zealand	Optimal Clinical Trials Ltd	Auckland
New Zealand	Southern Clinical Trials Waitemata	Auckland
New Zealand	Southern Clinical Trials Limited	Christchurch	Canterbury
New Zealand	Southern Clinical Trials - Tasman	Nelson
New Zealand	Lakeland Clinical Trials	Rotorua	Canterbury
Panama	CEVAXIN 24 de diciembre	Panamá
Panama	CEVAXIN Avenida México	Panamá	Calidonia
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku	Gdansk	Pomorskie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach	Katowice	Slaskie
Poland	Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik	Ostrowiec Swietokrzyski	Swietokrzyskie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu	Poznan	Wielkopolskie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie	Warszawa	Mazowieckie
Poland	AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu	Wroclaw	Dolnoslaskie
Puerto Rico	BRCR Global Puerto Rico (Ponce)	Ponce
Puerto Rico	Caribbean Medical Research Center	San Juan
Puerto Rico	Proyecto ACTU	San Juan
Singapore	Singapore General Hospital (SGH)	Singapore
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	AES - DRS - Synexus - Stanza Clinical Research Centre	Pretoria	Gauteng
South Africa	AES - DRS - Synexus Watermeyer Clinical Research Centre	Pretoria	Gauteng
South Africa	Dr. J Breedt	Pretoria	Gauteng
South Africa	AES - DRS - Synexus - Helderberg Clinical Research Centre	Somerset West	Western Cape
South Africa	Aliwal Shoal Medical Center	Umkomaas	Kwazulu - Natal
Spain	ABS Centelles	Centelles	Barcelona
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario La Paz - PPDS	Madrid
Spain	Hospital Son Llatzer	Son Ferriol	Palma De Mallorca
Spain	FISABIO Oftalmología Médica (FOM)	Valencia
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	China Medical University Hospital - PPDS	Taichung City
Taiwan	Taipei Veterans General Hospital	Taipei City
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City
United Kingdom	AES - DRS - Synexus Scotland Clinical Research Centre	Bellshill
United Kingdom	AES - DRS - Synexus Midlands Clinical Research Centre	Birmingham
United Kingdom	Layton Medical Centre	Blackpool
United Kingdom	Bristol Royal Infirmary	Bristol	Avon
United Kingdom	AES - DRS - Synexus Wales Clinical Research Centre	Cardiff
United Kingdom	AES - DRS - NW Consortium Lancashire	Chorley	Lancashire
United Kingdom	AES - DRS - Synexus Hexham Clinical Research Centre	Hexham	Northumberland
United Kingdom	AES - DRS - NW Consortium Merseyside	Liverpool
United Kingdom	AES - DRS - NW Consortium Manchester	Manchester
United Kingdom	Royal Victoria Infirmary	Newcastle Upon Tyne	Tyne And Wear
United Kingdom	Cheadle Hospital	Stoke-On-Trent	Staffordshire
United States	Privia Medical Group, LLC - Annapolis - Javara - PPDS	Annapolis	Maryland
United States	Mount Vernon Clinical Research, LLC - M3 WR	Atlanta	Georgia
United States	Masters of Clinical Research Inc	Augusta	Georgia
United States	Lynn Institute of Denver	Aurora	Colorado
United States	Premier Family Physicians - Austin - Hunt - PPDS	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Velocity Clinical Research, Banning	Banning	California
United States	Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS	Baton Rouge	Louisiana
United States	Accel Research Site - Achieve - Birmingham	Birmingham	Alabama
United States	AES - DRS - Synexus Clinical Research US, Inc. - Birmingham	Birmingham	Alabama
United States	Cope Family Medicine - CCT - PPDS	Bountiful	Utah
United States	PanAmerican Clinical Research LLC	Brownsville	Texas
United States	Hope Clinical Research, LLC	Canoga Park	California
United States	ACRC Trials - Carrollton - Hunt - PPDS	Carrollton	Texas
United States	AES - DRS - Synexus Clinical Research US, Inc. - Chicago	Chicago	Illinois
United States	Velocity Clinical Research - Chula Vista - PPDS	Chula Vista	California
United States	AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati	Cincinnati	Ohio
United States	CTI Clinical Research	Cincinnati	Ohio
United States	Velocity Clinical Research (Cincinnati - Ohio) - PPDS	Cincinnati	Ohio
United States	Velocity Clinical Research - Cincinnati - PPDS	Cincinnati	Ohio
United States	Alpine Research Organization, Inc	Clinton	Utah
United States	Centricity Research - Roswell - HyperCore - PPDS	Columbus	Georgia
United States	Benchmark Research - Covington - HyperCore - PPDS	Covington	Louisiana
United States	AES - DRS - Synexus Clinical Research US, Inc. - St. Louis	Creve Coeur	Missouri
United States	PPD Virtual - Science 37, Inc	Culver City	California
United States	Velocity Clinical Research (Dakota Dunes - South Dakota) - PPDS	Dakota Dunes	South Dakota
United States	iResearch Atlanta	Decatur	Georgia
United States	Velocity Clinical Research - East Syracuse - PPDS	East Syracuse	New York
United States	Velocity Clinical Research, New Smyrna Beach	Edgewater	Florida
United States	Tekton Research - Oklahoma - PPDS	Edmond	Oklahoma
United States	Skyline Medical Center, PC - CCT Research	Elkhorn	Nebraska
United States	Velocity Clinical Research (Endwell - New York) - PPDS	Endwell	New York
United States	AES - DRS - Synexus Clinical Research US, Inc. - Evansville	Evansville	Indiana
United States	Carolina Institute for Clinical Research - M3 WR	Fayetteville	North Carolina
United States	Javara, Inc./Privia Medical Group Georgia, LLC	Fayetteville	Georgia
United States	Fleming Island Clinical Research Center	Fleming Island	Florida
United States	Tekton Research - Fort Collins - PPDS	Fort Collins	Colorado
United States	Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS	Fort Worth	Texas
United States	Methodist Physicians Clinic - CCT Research - PPDS	Fremont	Nebraska
United States	Allure Health LLC	Friendswood	Texas
United States	Olympus Family Medicine- CCT	Friendswood	Texas
United States	Village Health Partners Frisco Medical Village	Frisco	Texas
United States	CBH Health - CenExel CBH - PPDS	Gaithersburg	Maryland
United States	Velocity Clinical Research (Grand Island - Nebraska) - PPDS	Grand Island	Nebraska
United States	Triad Clinical Trials	Greensboro	North Carolina
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	Velocity Clinical Research - Hallandale Beach - PPDS	Hallandale Beach	Florida
United States	Drug Trials America	Hartsdale	New York
United States	Hatboro Medical Associates - CCT - PPDS	Hatboro	Pennsylvania
United States	East West Medical Research Institute	Honolulu	Hawaii
United States	DM Clinical Research - Bellaire - ERN - PPDS	Houston	Texas
United States	West Houston Clinical Research - Hunt - PPDS	Houston	Texas
United States	DM Clinical-TCDD	Humble	Texas
United States	Hope Research Institute LLC - Hunt - PPDS	Hunt	Arizona
United States	Hope Research Institute LLC - Hunt - PPDS	Hunt	Arizona
United States	AES - DRS - Optimal Research Alabama - Huntsville	Huntsville	Alabama
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Helios CR, Inc. - Houston - PPDS	Keller	Texas
United States	Velocity Clinical Research, San Diego	La Mesa	California
United States	Multi-Specialty Research Associates, Inc. M3 WR	Lake City	Florida
United States	Excel Clinical Research - Las Vegas	Las Vegas	Nevada
United States	HEALOR Primary Care - Physicians Las Vegas - CCT	Las Vegas	Nevada
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Velocity Clinical Research (Lincoln - Nebraska) - PPDS	Lincoln	Nebraska
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Tekton Research - Longmont - PPDS	Longmont	Colorado
United States	PRI, LLC - Los Alamitos - M3 WR	Los Alamitos	California
United States	Accel Research Sites - Maitland - ERN - PPDS	Maitland	Florida
United States	Drug Studies America - ClinEdge - PPDS	Marietta	Georgia
United States	Velocity Clinical Research - Boise - PPDS	Meridian	Idaho
United States	Desert Clinical Research, LLC - CCT	Mesa	Arizona
United States	Benchmark Research - Metairie - HyperCore - PPDS	Metairie	Louisiana
United States	Spotlight Research Center, LLC	Miami	Florida
United States	IMA Clinical Research - Manhattan - PPDS	Miami Beach	Florida
United States	Clinical Research Consultants LLC - ClinEdge - PPDS	Milford	Connecticut
United States	Clinical Research Institute, Inc - CRN - PPDS	Minneapolis	Minnesota
United States	Boeson Research MSO - Missoula - ERN - PPDS	Missoula	Montana
United States	Montana Medical Research	Missoula	Montana
United States	IMA Clinical Research - Monroe, LA - PPDS	Monroe	Louisiana
United States	Affinity Health - Nashville	Nashville	Tennessee
United States	DelRicht Clinical Research, LLC - Internal - Covington - PPDS	New Orleans	Louisiana
United States	AES - DRS - Synexus Clinical Research US, Inc. - New York	New York	New York
United States	PRI, LLC - Newport Beach - M3 WR	Newport Beach	California
United States	Health Research of Hampton Roads Inc.	Newport News	Virginia
United States	Affinity Health (Oak Brook)	Oak Brook	Illinois
United States	Velocity Clinical Research (Omaha - Nebraska) - PPDS	Omaha	Nebraska
United States	AES - DRS - Synexus Clinical Research US, Inc. - The Villages	Orlando	Florida
United States	FOMAT Medical Research - FOMAT - HyperCore - PPDS	Oxnard	California
United States	CCT Research	Papillion	Nebraska
United States	Randomize Now -Commerce Dr	Peachtree City	Georgia
United States	DM Clinical Research - Philadelphia - ERN - PPDS	Philadelphia	Pennsylvania
United States	AES - DRS - Synexus Clinical Research US, Inc. - Phoenix Central	Phoenix	Arizona
United States	Hope Research Institute LLC - Phoenix - Hunt - PPDS	Phoenix	Arizona
United States	Synexus Clinical Research US, Inc. - Phoenix Southeast	Phoenix	Arizona
United States	AIM Trials	Plano	Texas
United States	Reddy Care Medical	Pomona	California
United States	Health Awareness Inc	Port Saint Lucie	Florida
United States	Summit Research Network, Inc. - Portland - Headlands - PPDS	Portland	Oregon
United States	Velocity Clinical Research - Family Practice - Portsmouth - PPDS	Portsmouth	Virginia
United States	American Indian Clinical Trials Research Network	Rapid City	South Dakota
United States	IMA Clinical Research - Raritan - PPDS	Raritan	New Jersey
United States	Paradigm Clinical Research Institute Inc - ClinEdge - PPDS	Redding	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis	Richfield	Minnesota
United States	DM Clinical - Chicago	River Forest	Illinois
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Velocity Clinical Research (Rockville - Maryland) - PPDS	Rockville	Maryland
United States	AES - DRS - Synexus Clinical Research US, Inc. - St. Petersburg	Saint Petersburg	Florida
United States	IMA Clinical Research - Saint Petersburg - PPDS	Saint Petersburg	Florida
United States	AES - DRS - Synexus Clinical Research US, Inc. - San Antonio	San Antonio	Texas
United States	Clinical Trials of Texas, LLC - HyperCore - PPDS	San Antonio	Texas
United States	Medical Center For Clinical Research - M3 WR	San Diego	California
United States	Velocity Clinical Research (Savannah - Georgia) - PPDS	Savannah	Georgia
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Riverside Medical Group - Circuit - PPDS	Secaucus	New Jersey
United States	South Ogden Family Medicine - CCT	South Ogden	Utah
United States	DM Clinical Research - Southfield - ERN - PPDS	Southfield	Michigan
United States	Great Lakes Research Institute	Southfield	Michigan
United States	Privia Medical Group- North Texas - Stephenville - Javara - PPDS	Stephenville	Texas
United States	Clinical Research Atlanta - ERN-PPDS	Stockbridge	Georgia
United States	DM Clinical Research - Sugarland - ERN - PPDS	Sugar Land	Texas
United States	Clinical Trials of Tampa	Tampa	Florida
United States	DM Clinical Research - ERN	Tomball	Texas
United States	DM Clinical Research - ERN - PPDS	Tomball	Texas
United States	Tucson Neuroscience Research - M3 WR	Tucson	Arizona
United States	Velocity Clinical Research - Valparaiso - PPDS	Valparaiso	Indiana
United States	Versailles Family Medicine - CCT - PPDS	Versailles	Kentucky
United States	Washington Health Institute	Washington	District of Columbia
United States	Palm Beach Research - ClinEdge - PPDS	West Palm Beach	Florida
United States	Paradigm Clinical Research Institute Inc - ClinEdge - PPDS	Wheat Ridge	Colorado
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Clinical Site Partners - Winter Park - HyperCore -PPDS	Winter Park	Florida
United States	Tekton Research	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bangladesh,  Belgium,  Canada,  Chile,  Colombia,  Costa Rica,  Finland,  Germany,  Japan,  Korea, Republic of,  Mexico,  New Zealand,  Panama,  Poland,  Puerto Rico,  Singapore,  South Africa,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to 7 days after each injection
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to 28 days after each injection
Primary	Number of Participants With Medically Attended AEs (MAAEs), Adverse Events of Special Interests (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Withdrawal		Up to BD Day 181
Primary	Vaccine Efficacy (VE) of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 2 or More Symptoms	VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
Primary	VE of mRNA-1345 to Prevent a First Episode of RSV-LRTD with 3 or More Symptoms	VE of mRNA-1345 to prevent reverse transcription polymerase chain reaction (RT-PCR) confirmed protocol-defined RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
Primary	Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies		BD Day 29
Primary	Geometric Mean Ratio (GMR) of Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose		BD Day 29
Secondary	VE of mRNA-1345 to Prevent a First Episode of RSV-Associated Acute Respiratory Disease (RSV-ARD)	VE of mRNA-1345 to prevent RT-PCR confirmed protocol-defined RSV-ARD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
Secondary	VE of mRNA-1345 to Prevent First Hospitalization Associated with RSV-ARD or RSV-LRTD	VE of mRNA-1345 to prevent first hospitalization associated with RSV-ARD or RSV-LRTD, defined as 100*(1-HR ratio), where HR is the hazard ratio (mRNA-1345 versus placebo).	From 14 days postinjection up to 12 months postinjection
Secondary	GMT of Serum RSV Neutralizing Antibodies		Baseline through up to 24 months postinjection
Secondary	Geometric Mean Concentration (GMC) of Serum RSV Binding Antibodies		Baseline through up to 24 months postinjection
Secondary	Seroresponse Rate in RSV Neutralizing Antibodies		Baseline through up to 24 months postinjection
Secondary	Geometric Mean Fold-Rise (GMFR) of Postbaseline/Baseline Antibody Titers		Baseline through up to 24 months postinjection
Secondary	Proportion of Participants with =4-fold Increases in Antibody Titers from Baseline		Baseline through up to 24 months postinjection
Secondary	Seroresponse Rate (SRR) Difference Between Serum RSV-A and RSV-B Neutralizing Antibodies After BD Compared to After Initial Dose		BD Day 29
Secondary	GMT of Serum RSV-A and RSV-B Neutralizing Antibodies		BD Day 1 and Day 181
Secondary	GMFR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)		Baseline, BD Day 1, Day 29 and Day 181
Secondary	SRR of Serum RSV-A and RSV-B Neutralizing Antibodies from Pre-primary Dose (Baseline)		Baseline, BD Day 1, Day 29 and Day 181