Clinical trial NCT06508320: A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)
Official title: A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity in Relation to the Product Attributes of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Adults ≥50 to <65 Years of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Influenza
SARS-CoV-2
Keywords: Influenza
SARS-CoV-2
mRNA-1083
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 932
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.

Detailed description: The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.

Eligibility criteria: Inclusion Criteria:

1. Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
2. Participants of nonchildbearing potential may be enrolled in the study.
3. Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy.
4. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
5. Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2).

Exclusion Criteria:

1. Reported diagnosis or condition that is associated with increased risk of severe influenza disease or complications, including individuals with chronic medical conditions.
2. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
3. History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
4. Received corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
5. Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., infliximab), within 180 days prior to Day 1 or plans to do so during the study.
6. Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
7. Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
8. Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1.
9. Received any investigational influenza vaccine, investigational coronavirus disease 2019 (COVID-19) vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. Participants from mRNA-1083-P201 Part 1 will also be excluded from Part 2.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Geometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza
timeFrame: Day 29
measure: Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2
timeFrame: Day 29
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 7 (7 days after vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 28 (28 days after vaccination)
measure: Number of Participants with Medically Attended Adverse Events (MAAEs)
timeFrame: Up to Day 181
measure: Number of Participants with Adverse Events of Special Interest (AESIs)
timeFrame: Up to Day 181
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 181
measure: Number of Participants with AEs Leading to Discontinuation from Study Participation
timeFrame: Up to Day 181
Secondary outcomes:
measure: Geometric Mean Fold Rise (GMFR) of Antibodies at Day 29 Relative to Day 1, as Measured by HAI Assay for Influenza
timeFrame: Day 1, Day 29
measure: GMFR of Antibodies at Day 29 Relative to Day 1, as Measured by PsVNA for SARS-CoV-2
timeFrame: Day 1, Day 29
measure: Seroconversion Rate (SCR) in Anti-hemagglutinin (HA) Antibody Values at Day 29, as Measured by HAI Assay for Influenza
timeFrame: Day 29
measure: Seroresponse Rate (SRR) in Neutralizing Antibody (nAb) Values at Day 29, as Measured by PsVNA for SARS-CoV-2
timeFrame: Day 29
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc.
state: Florida
city: Hollywood
country: United States
facility: Cenexel RCA
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC DBA Flourish Research
state: Florida
city: Decatur
country: United States
facility: Cenexel IRA
state: Georgia
city: River Forest
country: United States
facility: DM Clinical Research - River Forest
state: Illinois
city: Lenexa
country: United States
facility: JCCT
state: Kansas
city: Marlton
country: United States
facility: Hassman Research Institute - Berlin - CenExel - PPDS
state: New Jersey
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: DM Clinical Research - Cyfair Clinical Research Center - PPDS
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC DBA Flourish Research
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugarland
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball MDC
state: Texas
city: Toronto
country: Canada
facility: Centricity Research
state: Ontario
city: Toronto
country: Canada
facility: Centricity Research
state: Ontario
city: Pointe-Claire
country: Canada
facility: Centricity Research
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc.
state: Quebec
city: Québec
country: Canada
facility: Diex Recherche Québec Inc.
Study officials:
References: