A Study of mRNA-1010 Seasonal Influenza Vaccine in Adults 50 Years Old and Older

Seasonal Influenza Clinical Trial

Official title:

A Phase 3, Randomized, Observer-blind, Active-controlled Study to Evaluate the Safety and Efficacy of mRNA-1010 Candidate Seasonal Influenza Vaccine in Adults 50 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05566639
• Other study ID #: mRNA-1010-P302
• Secondary ID: 2022-001638-12
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2022
• Est. completion date: January 5, 2024

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of mRNA-1010 in preventing seasonal influenza in adults 50 years and older.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22510
• Est. completion date: January 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow-up, including all procedures.

• 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 the first dose on Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.

Exclusion Criteria:

• Participant has had close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®) within the past 5 days prior to the Screening visit.

• Participant has had close contact to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 as defined by the US CDC or has had a positive SARS-CoV-2 test in the past 10 days prior to the Screening visit.

• Participant is acutely ill or febrile (temperature =38.0?elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window.

• Participant has a history of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.

• Reported history of congenital or acquired immunodeficiency, immunocompromising/ immunosuppressive condition, asplenia, or recurrent severe infections.

• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA or influenza vaccines or any components of the mRNA or influenza vaccines, including egg protein.

• Participant has received systemic immunosuppressant drugs for >14 days in total within 180 days prior to the Screening visit (for glucocorticosteroids, =10 milligrams (mg)/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled, nasal, and topical steroids are allowed.

• Participant has received any vaccine authorized or approved by local health agency =28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.

• Participant is unaware whether they have received an influenza vaccine in the previous influenza season.

• Participant received a seasonal influenza vaccine or any other investigational influenza vaccine within 180 days prior to Day 1

• Participant has tested positive for influenza by local health authority-approved testing methods within 180 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 study.

Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• mRNA-1010
Sterile liquid for injection
• Licensed quadrivalent inactivated seasonal influenza vaccine
Sterile suspension for injection.

Locations

Country	Name	City	State
Bulgaria	MHAT Sveti Ivan Rilski	Kozloduy
Bulgaria	MC City Clinic Sveti Georgi - Montana	Montana
Bulgaria	MHAT "Dr. Stamen Iliev	Montana
Bulgaria	Medical Center Medconsult Pleven	Pleven
Bulgaria	Military Medical Academy	Sofia
Bulgaria	SHAT of Pneumo-phthisiatric diseases - Sofia District	Sofia
Canada	Aggarwal and Associates LTD	Brampton
Canada	Aviva Clinical Trials Group Inc	Burlington
Canada	Hamilton Medical Research Group	Hamilton
Canada	Okanagan Clinical Trials	Kelowna
Canada	Centricity Research Quebec City	Levis
Canada	Milestone Research Inc.	London
Canada	Yang Medicine	Ottawa
Canada	LMC Manna	Pointe-Claire
Canada	Alpha Recherche Clinique Inc	Quebec
Canada	Clinique de Lebourgneuf	Quebec
Canada	Clinique spécialisée en allergie - Allergy/Immunology/Asthma/Mpoc	Quebec
Canada	DIEX Research Quebec Inc.	Quebec
Canada	DIEX Research Quebec Inc.	Quebec
Canada	Diex Research Sherbrooke Inc	Quebec
Canada	Central Alberta Research Clinic	Red Deer
Canada	Diex Recherche - Joilette - HyperCore - PPDS	Saint-Charles-Borromée
Canada	Glencar Medical Inc.	Sarnia
Canada	Canadian Phase Onward Inc.	Toronto
Canada	LMC	Toronto
Canada	Manna Research	Toronto
Canada	Medicine Professional Corporation	Toronto
Canada	Toronto Western Hospital	Toronto
Canada	Diex Recherche Trois-Rivières	Trois-Rivieres
Canada	Colchester East Hants Health Authority - Colchester Regional	Truro
Canada	Diex Recherche Victoriaville	Victoriaville
Denmark	Aarhus Universitetshospital	Århus N
Denmark	Odense University Hospital	Odense
Denmark	Sjællands UniHosp, Roskilde - Medicine and Infectious Diseases	Roskilde
Estonia	Center for Clinical and Basic Research	Tallinn
Estonia	Innomedica OÜ	Tallinn
Estonia	Merelahe Family Doctors Centre	Tallinn
Estonia	Clinical Research Center	Tartu
Germany	Berliner Centrum für Reise- und Tropenmedizin	Berlin
Germany	Emovis GmbH	Berlin
Germany	Klinische Forschung Berlin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Klinische Forschung Dresden GmbH	Dresden
Germany	Medizentrum Essen Borbeck	Essen
Germany	IKF Pneumologie	Frankfurt
Germany	Infektiologikum Frankfurt-Sachsenhausen	Frankfurt
Germany	Studienzentrum Dr. Keller	Frankfurt/Main
Germany	Clinical Research Hamburg GmbH	Hamburg
Germany	Klinische Forschung Hamburg GmbH	Hamburg
Germany	Klinische Forschung Hannover-Mitte GmbH	Hannover
Germany	Siteworks GmbH	Hannover
Germany	Siteworks GmbH	Heidelberg
Germany	University Hospital Cologne AöR	Köln
Germany	Synexus Clinical Research GmbH	Leipzig
Germany	Praxis Illies	Magdeburg
Germany	Dermatologie Quist	Mainz
Germany	Praxis Schaum	Oldenburg
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Germany	Hautarztpraxis Leitz & Kollegen	Stuttgart
Germany	Studienzentrum Brinkum	Wardenburg
Netherlands	Leids Universitair Medisch Centrum (LUMC)	Leiden
Netherlands	Universitair Medisch Centrum (UMC) Utrecht - Julius Center for Health Sciences and Primary Care	Utrecht
Poland	Centrum Medyczne Pratia Bydgoszcz	Bydgoszcz
Poland	Centrum Medyczne Plejady	Krakow
Poland	Krakowskie Centrum Medyczne Sp. z o.o.	Kraków
Poland	Centrum Medyczne AMED Oddzial w Lodzi	Lodz
Poland	ETG Lublin	Lublin
Poland	KO-MED Centra Kliniczne Lublin II	Lublin
Poland	ETG Skierniewice	Skierniewice
Poland	Centrum Innowacyjnych Terapii Sp. z o.o.	Warszawa
Poland	Provita Centrum Medyczne Sp. z o.o.	Warszawa
Poland	RCMed	Warszawa
Poland	ETG Zamosc	Zamosc
Poland	KO-MED Centra Kliniczne Sp. z o.o.	Zamosc
Spain	Hospital de Antequera	Antequera
Spain	Hospital Clinic De Barcelona	Barcelona
Spain	Hospital Santa Creu i Sant Pau - Research institut	Barcelona
Spain	Universitat Autonoma de Barcelona (UAB) - Institut d'Investigacio en Atencio Primaria Jordi Gol (IDIAP Jordi Gol)	Barcelona
Spain	Hospital Alvaro Cunqueiro	Vigo
Spain	Hospital Povisa	Vigo
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City
Taiwan	China Medical University Hospital - division of Rheumatology - Taichung	Taichung
Taiwan	National Cheng Kung University hospital	Tainan
Taiwan	National Taiwan University Hospital - Family Medicine	Taipei
Taiwan	Taipei Medical University - Taipei Medical University Hospital	Taipei
Taiwan	Taipei Medical University - WanFang Hospital	Taipei
Taiwan	Tri-Service General Hospital - Neihu Branch - Infectious Diseases	Taipei
United Kingdom	Royal United Hospital	Bath
United Kingdom	Layton Medical Centre	Blackpool
United Kingdom	Hull University Teaching Hospitals NHS Foundation trust	Hull
United Kingdom	University Hospitals of Leicester-Leicester Royal Hospital	Leicester
United Kingdom	Liverpool University Hospitals NHS Foundation Trust - Aintree University Hospital (Fazakerley Hospital)	Liverpool
United Kingdom	GST NHS Found	London
United Kingdom	Newcastle University - Institute of Cellular Medicine (ICM)	Newcastle
United Kingdom	Panthera Biopartners - Manchester - multispeciality	Rochdale
United Kingdom	Panthera Biopartners - Sheffield - multispeciality	Rochdale
United Kingdom	Panthera Biopartners - Preston - multispeciality	Salford
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Royal Cornwall Hospitals Trust - Respiratory	Truro
United States	Radiant Research	Akron	Ohio
United States	Velocity Clinical Research, Greenville	Anderson	South Carolina
United States	Privia Medical Group	Annapolis	Maryland
United States	North Alabama Research Center, LLC	Athens	Alabama
United States	Tekton Research, Inc	Austin	Texas
United States	Velocity Clinical Research, Banning	Banning	California
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Platinum Research Network, LLC	Beaumont	Texas
United States	Paul G Matherne MD	Biloxi	Mississippi
United States	United Medical Associates	Binghamton	New York
United States	Cope Family Medicine	Bountiful	Utah
United States	Hope Clinical Research, LLC	Canoga Park	California
United States	Tekton Research, Inc.	Chamblee	Georgia
United States	Tryon Medical Group	Charlotte	North Carolina
United States	Great Lakes Clinical Trials LLC	Chicago	Illinois
United States	Great Lakes Clinical Trials LLC	Chicago	Illinois
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Sterling Research Group	Cincinnati	Ohio
United States	Velocity Clinical Research - Cincinnati	Cincinnati	Ohio
United States	Velocity Clinical Research - Columbia	Columbia	South Carolina
United States	Southeast Regional Research Group	Columbus	Georgia
United States	MedPharmics	Covington	Louisiana
United States	Nature Coast Clinical Research, LLC - Crystal River	Crystal River	Florida
United States	Zenos Clinical Research	Dallas	Texas
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Velocity Clinical Research, Denver	Denver	Colorado
United States	CCT Research at Skyline Medical Center, PC	Elkhorn	Nebraska
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Arthritis & Rheumatology - Clinic of Northern Colorado	Fort Collins	Colorado
United States	Benchmark Research	Fort Worth	Texas
United States	CCT Research / Methodist Physicians Clinic, Prairie Fields Family Medicine, PC	Fremont	Nebraska
United States	Velocity Clinical Research, Gaffney	Gaffney	South Carolina
United States	Lenzmeier Family Medicine	Glendale	Arizona
United States	Meridian Clinical Research	Grand Island	Nebraska
United States	Velocity Clinical Research - Grants Pass	Grants Pass	Oregon
United States	Velocity Clinical Research - Greenville	Greenville	South Carolina
United States	DELRICHT RESEARCH at GULFPORT MEMORIAL	Gulfport	Mississippi
United States	Great Lakes Clinical Trials LLC	Gurnee	Illinois
United States	Delricht Research	Hendersonville	Tennessee
United States	Floridian Clinical Research	Hialeah	Florida
United States	Homestead Associates in Research,Inc	Hialeah	Florida
United States	Olympus Family Medicine/CCT Research	Holladay	Utah
United States	Broward Research Group	Hollywood	Florida
United States	DM Clinical Research	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Citrus Cardiology Consultants	Inverness	Florida
United States	Encore Research Group-Jacksonville Center for Clinical Resea	Jacksonville	Florida
United States	Health Awareness, Inc	Jupiter	Florida
United States	Velocity Clinical Research, Chula Vista	La Mesa	California
United States	Velocity Clinical Research, San Diego	La Mesa	California
United States	Multi-Therapeutic Research Associates, Inc.	Lake City	Florida
United States	Accel Research Sites - Lakeland	Lakeland	Florida
United States	CCT Research	Las Vegas	Nevada
United States	Clinical Research Center of Nevada LLC	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada/ CCT Research	Las Vegas	Nevada
United States	Johnson County Clin-Trials (JCCT)	Lenexa	Kansas
United States	Be Well Clinical Studies, LLC	Lincoln	Nebraska
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Velocity Clinical Research - Westlake	Los Angeles	California
United States	ARS - Meridien Research	Maitland	Florida
United States	DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE	McKinney	Texas
United States	Velocity Clinical Resarch - Medford	Medford	Oregon
United States	Velocity Clinical Research - Boise	Meridian	Idaho
United States	Medpharmics, LLC	Metairie	Louisiana
United States	Clinical Trials of Florida, LLC	Miami	Florida
United States	Miami centre of clinical research	Miami	Florida
United States	South Florida Research Center, Inc.	Miami	Florida
United States	Suncoast Research Associates Trials, LLC	Miami	Florida
United States	Global Health Research Center	Miami Lakes	Florida
United States	Montana Medical Research, Inc	Missoula	Montana
United States	Diabetes & Endocrinology Consultants	Morehead City	North Carolina
United States	Carolina Health Specialists	Myrtle Beach	South Carolina
United States	Nathan H Fischman MD LLC	New Orleans	Louisiana
United States	Heartland Research Associates LLC	Newton	Kansas
United States	In-Quest Medical Research	Norcross	Georgia
United States	Medpace, Inc. - Clinical Pharmacology Unit (CPU)	Norfolk	Nebraska
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Las Vegas Clinical Trials, LLC	North Las Vegas	Nevada
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research - Omaha	Omaha	Nebraska
United States	Midwest Regional Health Services, LLC/CCT Research	Omaha	Nebraska
United States	Papillon Research Centre	Omaha	Nebraska
United States	Innovation Medical Research Center,inc	Palmetto Bay	Florida
United States	CCT Research	Phoenix	Arizona
United States	Research Your Health	Plano	Texas
United States	Empire Clinical Research	Pomona	California
United States	Meridian Clinical Research	Portsmouth	Virginia
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Black Hills Center for American Indian Health	Rapid City	South Dakota
United States	Epic Medical Research, LLC	Red Oak	Texas
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Chicago Health Medical Group	River Forest	Illinois
United States	Artemis Institute for Clinical Research	Riverside	California
United States	Benchmark Research-Texas	Riverside	California
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Rockville Internal Medicine Group	Rockville	Maryland
United States	Peninsula Research Associates (PRA)	Rolling Hills Estates	California
United States	Sundance Clinical Research, LLC	Saint Louis	Missouri
United States	CenExel - JBR	Salt Lake City	Utah
United States	Clinical Trials of Texas, Inc	San Antonio	Texas
United States	Acclaim Clinical Research	San Diego	California
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Medical Center for Clinical Research	San Diego	California
United States	Women's Health Care Research Corp.	San Diego	California
United States	Shawn K Hassler MD	San Francisco	California
United States	West Coast Research LLC	San Ramon	California
United States	Mount Vernon Clinical Research	Sandy Springs	Georgia
United States	Meridian Clinical Research - Savannah	Savannah	Georgia
United States	Meridian Clinical Research - Dakota Dunes	Sioux City	Iowa
United States	South Ogden Family Medicine clinic/CCT	South Ogden	Utah
United States	DM Clinical Research - Detroit	Southfield	Michigan
United States	Spartanburg Regional Health Services	Spartanburg	South Carolina
United States	Delricht Research	Springfield	Massachusetts
United States	National Medical University and Embryonic Tissues Center EmC	Springfield	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Lakeview Medical Center	Suffolk	Virginia
United States	Breco Research - A Tarheel Clinical Research Site	Sugar Land	Texas
United States	DM Clinical Research	Sugar Land	Texas
United States	Velocity Clinical Research - Syracuse	Syracuse	New York
United States	New Tampa Health, Inc	Tampa	Florida
United States	Fiel Family and Sports Medicine/CCT Research	Tempe	Arizona
United States	Noble Clinical Research	Tucson	Arizona
United States	Delricht Research Tulsa	Tulsa	Oklahoma
United States	Velocity Clinical Research - Valparaiso	Valparaiso	Indiana
United States	Velocity Clinical Research - Providence	Warwick	Rhode Island
United States	Velocity Clinical Research - Salt Lake City	West Jordan	Utah
United States	Alliance for Multispecialty Research	Wichita	Kansas
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Trial Management Associates	Wilmington	North Carolina
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	Platinum Research Network, LLC	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Denmark,  Estonia,  Germany,  Netherlands,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 7 (7 days after vaccination)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days after vaccination)
Primary	Number of Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation		Day 1 through Day 361
Primary	Time to First Episode of Reverse Transcription Polymerase Chain Reaction (RT-PCR) Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Any Influenza A or B Virus Strains		14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains with Similarity to the Vaccine Strains	Similarity to strains selected for the seasonal vaccine will be determined by antigenicity testing and/or genomic sequencing.	14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Time to First Episode of RT-PCR Confirmed Protocol-Defined ILI Caused by Any Influenza A or B Virus Strains Antigenically Matched to the Vaccine Strains	Antigenically matched to strains selected for the seasonal vaccine will be determined by antigenicity testing.	14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Time to First Episode of RT-PCR Confirmed United States (US) Centers for Disease Control and Prevention (CDC)-Defined ILI Caused by Any Influenza A or B Virus Strains	Any strains include any influenza A or B strains, influenza A or B strains with similarity to vaccine strains and influenza A or B strains that are antigenically matched to vaccine strains. Antigenically matched to strains selected for the seasonal vaccine will be determined by antigenicity testing.	14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Time to First Episode of Culture-Confirmed Protocol-Defined ILI Caused by Any Influenza A or B	Any influenza A or B strains regardless of antigenic match to strains selected for the seasonal vaccine.; A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR.	14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Time to First Episode of Culture-Confirmed CDC-Defined ILI Caused by Any Influenza A or B	Any influenza A or B strains regardless of antigenic match to strains selected for the seasonal vaccine.; A positive result for influenza infection by viral culture is needed, following a positive result for influenza infection by RT-PCR	14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Number of Participants With Hospitalizations Associated With RT-PCR Confirmed Protocol-Defined ILI		14 days post-vaccination through Day 181 or end of influenza season, whichever ends later
Secondary	Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay		Day 29
Secondary	Number of Participants Reaching Seroconversion as measured by HAI Assay	Seroconversion is defined as either a prevaccination HAI titer <1:10 and a postvaccination titer =1:40 or a prevaccination HAI titer =1:10 and a minimum 4-fold rise in postvaccination HAI antibody titer.	Day 29
Secondary	Number of Participants with a Titer =1:40 as Measured by HAI Assay		Day 29
Secondary	Change from Baseline in Geometric Mean Fold Rise (GMFR) at Day 29 as Measured by HAI Assay		Baseline, Day 29