Health TrialsbyHealthPanel

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations

ConditionCOVID-19
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorModernaTX, Inc.

About this trial

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥65 years of age at the time of signing the informed consent or ≥12 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.

Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.

Disqualifiers

History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.

Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number.

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.

Receipt of the COVID-19 vaccine within 6 months prior to enrollment.

Trial design

Design model

Single group

Treatments tested in this trial

  • mRNA-1283.251 Variant-containing Formulation

    Biological/Vaccine

    Sterile liquid for injection

Treatment groups

832 Participants
are divided into 1 treatment group
Group A: mRNA-1283.251 Variant-containing FormulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Subprotocol 1: Part A - Geometric Mean (GM) Value of Neutralizing Antibody (nAb) Against Vaccine-matched COVID-19 Variants

Time frame
Day 29
2

Subprotocol 1: Part A - Geometric Mean Fold Rise (GMFR) of nAb Against Vaccine-matched COVID-19 Variants

Time frame
Baseline to Day 29
3

Subprotocol 1: Part B - GMFR of nAb Against Vaccine-matched COVID-19 Variants

Time frame
Baseline to Day 29
4

Subprotocol 1: Part A - Seroresponse Rate (SRR) of nAb Against Vaccine-matched COVID-19 Variants

Time frame
Baseline to Day 29

Secondary outcomes

1

Subprotocol 1: Part A - Number of Participants with Unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interests (AESIs), and AEs Leading to Study Withdrawal

Time frame
Day 1 through Day 29
2

Subprotocol 1: Part B - Number of Participants with Unsolicited AEs

Time frame
Day 1 through Day 29
3

Subprotocol 1: Part B - Number of Participants with SAEs, AESIs, and AEs Leading to Study Withdrawal

Time frame
Day 1 through Day 181
4

Subprotocol 1: Part B - Geometric Mean Ratio (GMR) of nAb Against Vaccine-matched COVID-19 Variants Between Participants Aged ≥12 to <65 Years and Those Aged ≥65 Years

Time frame
Day 29

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModernaTX, Inc.

Lead sponsor

Source ClinicalTrials.gov
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