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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05868382
Other study ID # mRNA-CRID-004
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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