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

Moderna

Status and phase: Enrolling; Phase 4

Conditions: SARS-CoV-2

Treatments: Biological: mRNA-1273 Variant-containing Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06585241

mRNA-1273-P403

Details and patient eligibility

About

The purpose of this study is to investigate the immunogenicity 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).

Full description

This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1273 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated variant vaccine, a new subprotocol will be generated.

Enrollment: 764 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• mRNA-1273.167 and mRNA-1273.712: Previously vaccinated adults aged ≥18 years

• mRNA-1273.251: Participants ≥65 years or ≥12 to <65 years of age 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.

Key Exclusion Criteria:

• History of SARS-CoV-2 infection 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.
• 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.
• Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 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) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
• Receipt of systemic immunoglobulins 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) 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.

Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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764 participants in 1 patient group

mRNA-1273 Variant-containing Formulation

Experimental group

Description:

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

Treatment:

Biological: mRNA-1273 Variant-containing Formulation