COVID-19
Conditions
Interventions
Trade Name: mNEXSPIKE
Product Name: mRNA-1283.251
Pharmaceutical Form: Injection
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subprotocol 1: - =65 years of age at the time of signing the informed consent or =12 to =65 years) yes F.1.3.1 Number of subjects for this age range 392
Exclusion criteria
Exclusion criteria: Subprotocol 1: - 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. - 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 for >14 days in total, within 180 days prior to Screening Visit (for corticosteroids =10 milligrams [mg]/day of prednisone equivalent) 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 responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study. - 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. - Has donated =450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immune response elicited by an updated mRNA-1283.251 COVID-19 variant-containing vaccine against the vaccine matched variant virus.;Secondary Objective: To evaluate the safety and reactogenicity of an updated mRNA-1283.251 COVID-19 variant-containing vaccine.;Primary end point(s): 1. Subprotocol 1: Part A - Geometric Mean (GM) Value of Neutralizing Antibody (nAb) Against Vaccine-matched COVID-19 Variants 2. Subprotocol 1: Part A - Geometric Mean Fold Rise (GMFR) of nAb Against Vaccine-matched COVID-19 Variants 3. Subprotocol 1: Part B - GMFR of nAb Against Vaccine-matched COVID-19 Variants 4. Subprotocol 1: Part A - Seroresponse Rate (SRR) of nAb Against Vaccine-matched COVID-19 Variants;Timepoint(s) of evaluation of this end point: Primary endpoint 1: Day 29 Primary endpoints 2 to 4: Baseline to Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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 2. Subprotocol 1: Part B - Number of Participants with Unsolicited AEs 3. Subprotocol 1: Part B - Number of Participants with SAEs, AESIs, and AEs Leading to Study Withdrawal 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 5. Subprotocol 1: Part B - Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs);Timepoint(s) of evaluation of this end point: Secondary endpoints 1 and 2: Day 1 through Day 29 Secondary endpoint 3: Day 1 through Day 181 Secondary endpoint 4: Day 29 Secondary endpoint 5: 7 days post vaccination | — |
Countries
United States
Contacts
Public ContactModerna WeCare Team
ModernaTX, Inc.
Outcome results
None listed