A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations

NCT06585241 | Recruiting Phase 4 FDA Drug

• 1 other identifier: mRNA-1273-P403
• Study Type: interventional
• Target: 1,144
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to investigate the immunogenicity and safety of mRNA COVID-19 variant-containing vaccine formulations against the vaccine-matched variants and newly emerged variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Conditions

SARS-CoV-2

Keywords

mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Variant; Moderna; Pediatric

Outcome Measures

Primary Outcomes (3)

• mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants

  Up to Day 29

• mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants

  Up to 28 days after last dose of study intervention

• mRNA-1273.251 and mRNA-1273.261: Seroresponse Rate

  Up to Day 29

Secondary Outcomes (4)

• mRNA-1273.251: Geometric Mean Titer of Neutralizing Antibody Against COVID-19 Variants of Participants ≥12 to <65 Years Old and ≥65 Years Old

  Day 29

• mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Number of Participants with Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Withdrawal, and AEs of Special Interest

  Day 1 through end of study (up to Day 209)

• mRNA-1273.251: Number of Participants with Solicited Local and Systemic Adverse Reactions

  Day 1 through 7 days after last dose of study intervention

• mRNA-1273.251 and mRNA-1273.261: Number of Participants with Unsolicited AEs

  Day 1 through 28 days after last dose of study intervention

Study Arms (1)

mRNA-1273 Variant-containing Formulation

EXPERIMENTAL

Participants will receive intramuscular (IM) injection(s) of an mRNA-1273 variant-containing formulation (mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, or mRNA-1273.261).

Biological: mRNA-1273 Variant-containing Formulation

Interventions

mRNA-1273 Variant-containing Formulation BIOLOGICAL

Sterile liquid for injection

mRNA-1273 Variant-containing Formulation

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years
• mRNA-1273.251: Participants ≥65 years of age, ≥12 to \<65 years of age, or ≥6 months to \<12 years of age with at least 1 risk factor for severe outcomes from COVID-19.
• mRNA-1273.261: ≥65 years of age at the time of signing the informed consent or ≥18 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.
• Able to comply with study procedures based on the assessment of the Investigator.
• Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
• Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.
• Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose.
• Has agreed to continue adequate contraception through 28 days following vaccine administration.

You may not qualify if:

• History of SARS-CoV-2 infection within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within up to 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261.
• Is acutely ill or febrile (temperature 38.0°Celsius/100.4°Fahrenheit) less than 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window.
• History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
• History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
• Receipt of COVID-19 vaccine within 3 months prior to enrollment for mRNA-1273.167 and mRNA-1273.712 or within 6 months prior to enrollment for mRNA-1273.251 and mRNA-1273.261.
• Receipt of any licensed non-COVID-19 vaccine within 14 days (inactivated vaccine, pediatric) or 28 days before or planned receipt within 14 days (pediatric) or 28 days after the study intervention, except an influenza vaccine, which may be given at least 7 days before (pediatric) or 14 days before or after receipt of the study intervention.
• Receipt of systemic immunosuppressants or immune-modifying drugs for \>14 days total (within 6 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 180 days prior to Screening for mRNA-1273.251 and mRNA-1273.261) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
• Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune (pediatric) responses, or blood products (within 3 months prior to Screening for mRNA-1273.167 and mRNA-1273.712 or within 90 days prior to the Screening for mRNA-1273.251 and mRNA-1273.261) or plans for receipt during the study.
• Has donated ≥450 milliliters of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (6)

CenExel

Atlanta, Georgia, 30331, United States

RECRUITING

CenExel

Decatur, Georgia, 30030, United States

RECRUITING

Velocity Clinical Research

Baton Rouge, Louisiana, 70809, United States

RECRUITING

Velocity Clinical Research

Gulfport, Mississippi, 39503, United States

RECRUITING

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

RECRUITING

Richard Bennett - Clinical Research Partners

Richmond, Virginia, 23226, United States

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Moderna WeCare Team

CONTACT

1-866-663-3762; WeCareClinicalTrials@modernatx.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 3b/4 open-label study.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 5, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (6)