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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05397223
Other study ID # mRNA-CRID-001
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date May 24, 2022
Est. completion date February 21, 2026

Study information

Verified date March 2024
Source ModernaTX, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 308
Est. completion date February 21, 2026
Est. primary completion date February 21, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Adults 18 to 75 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. For mRNA-1647 study arms, adults 18 to <50 years of age at the time of consent (screening visit) who, in the opinion of the investigator, are in good health based on review of medical history and physical examination performed at screening. - Body mass index (BMI) of 18 kilograms (kg)/square meter (m^2) to 35 kg/m^2 (inclusive) at the screening visit. Exclusion Criteria: - Participant has had close contact to someone with confirmed SARS-CoV-2, respiratory syncytial virus (RSV), or influenza infection in the past 14 days prior to the screening visit. - Severe allergic reaction to any component of the FLUAD vaccine (active comparator), including egg protein, or after a previous dose of any influenza vaccine. - Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to screening (to include any systemic corticosteroids) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - Participant plans to receive any licensed or authorized vaccine, including COVID-19 influenza vaccines, within 28 days before or after any study injection. - Participant has received a NH 2021 - 2022 or 2022-2023 seasonal influenza vaccine or any other influenza vaccine, or an experimental RSV or cytomegalovirus (CMV) vaccine, within 6 months prior to study Day 1, and/or has not completed a primary vaccination series for COVID-19. - Participant has received an authorized or approved COVID-19 vaccine within 4 months prior to Day 1, and/or has not completed a primary vaccination series for COVID-19. - Participant had a laboratory-confirmed infection with influenza or RSV within 6 months prior to Day 1, or SARS-CoV-2 within 4 months of Day 1. SARS-CoV-2 infection confirmed with self-administered, authorized or approved rapid antigen test is acceptable. - 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. - Participated in an interventional clinical study within 28 days prior to the screening visit based on the medical history interview or plans to do so while participating in this study until 12 months after their last study vaccination. Other inclusion and exclusion criteria may apply.

Study Design


Intervention

Biological:
mRNA-1273
Sterile liquid for injection
mRNA-1010
Sterile liquid for injection
mRNA-1345
Sterile liquid for injection
FLUAD®
adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine
mRNA-1647
Sterile lyophilized product

Locations

Country Name City State
United States Benchmark Research Austin Texas
United States Tekton Research, Inc Austin Texas
United States CenExel Hollywood Florida
United States DM Clinical Research- Texas Center for Drug Development Houston Texas
United States Johnson County Clinical Trials Lenexa Kansas
United States Meridian Clinical Research Lincoln Nebraska
United States Meridian Clinical Research Savannah Georgia
United States Meridian Clinical Research Sioux City Iowa

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 176 (7 days follow-up post-vaccination)
Primary Number of Participants With Unsolicited Adverse Events (AEs) Up to Day 197 (28 days follow-up post-vaccination)
Primary Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination Day 1 through end of study (EOS) (up to Day 1249)
Primary Number of Participants with Medically Attended Adverse Events (MAAEs) Day 1 through Day 361
Secondary Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345 Days 1 (Baseline), 29, 85, and 197
Secondary Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345 Days 1 (Baseline), 29, 85, and 197
Secondary Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647 Days 1 (Baseline), 29, 85, and 197
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