Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults

Influenza Clinical Trial

Official title:

A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05868382
• Other study ID #: mRNA-CRID-004
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2023
• Est. completion date: December 19, 2023

Study information

• Verified date: December 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: December 19, 2023
• Est. primary completion date: December 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

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 assigned females at birth and 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 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 Day 1.

• 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, immunosuppressive condition or immune-mediated disease, asplenia, or recurrent severe infections.

• Participant has tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.

• Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of mRNA vaccines or any components of the mRNA-1010 or influenza vaccines, including egg protein.

• Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, =10 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. Intra-articular and epidural steroid injections are not allowed within 28 days before and/or after study intervention dosing.

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

• Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1.

• Participant has participated in any investigational seasonal influenza vaccine study within12 months prior to Day 1.

• Participant is not aware whether they have received an influenza vaccine in the prior 12 months.

• Participant has donated =450 milliliters (mL) of blood products within 28 days prior to Day 1 or plans to donate blood products during the study.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• mRNA-1010
Sterile liquid for injection
• mRNA-1010.4
Sterile liquid for injection
• mRNA-1010.6
Sterile liquid for injection

Locations

Country	Name	City	State
United States	United Medical Associates	Binghamton	New York
United States	Meridian Clinical Research	Hastings	Nebraska
United States	CenExel RCA	Hollywood	Florida
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Meridian Clinical Research	Lincoln	Nebraska
United States	Suncoast Research Group	Miami	Florida
United States	Rockville Internal Medicine	Rockville	Maryland
United States	DM Clinical Research	Southfield	Michigan
United States	DM Clinical Research	Sugar Land	Texas
United States	Texas Center for Drug Development	Tomball	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

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 29 (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 181
Secondary	Change from Baseline in Geometric Mean Titer (GMT), as Measured by Hemagglutinin Inhibition (HAI) Assay		Baseline, Day 181
Secondary	Change from Baseline in Geometric Mean Fold Rise (GMFR) of Postinjection/Baseline, as Measured by HAI Assay		Baseline, Day 181
Secondary	Percentage of Participants with Seroresponse for mRNA-1010, as Measured by HAI Assay	Seroresponse is defined as an increase of antibody titers and concentrations from predose below the prespecified lower limit of quantification.	Day 181