Coronavirus Disease 2019 (COVID-19)
Conditions
Interventions
Product Name: mRNA-1273.167
Product Code: mRNA-1273.167
Pharmaceutical Form: Injection
Product Name: mRNA-1273.712
Product Code: mRNA-1273.712
Pharmaceutical Form: Injection
Product Name: mRNA-1273.
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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) yes F.1.3.1 Number of subjects for this age range 453
Exclusion criteria
Exclusion criteria: • 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 millilitres of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective 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 SARS-CoV-2.;Secondary Objective: - To evaluate the safety of the updated mRNA COVID-19 variant-containing vaccine - To compare the immune response elicited by the updated mRNA-1273.251 COVID-19 variant-containing vaccine against the vaccine matched variant virus, between participants aged =12 to <65 years and those aged =65 years - To evaluate the safety and reactogenicity of mRNA-1273.251 - To evaluate the safety and reactogenicity of a single injection of mRNA-1273.251 (or 2 injections for vaccine-naïve participants aged =6 months to <24 months) - To evaluate the safety of a single injection of mRNA-1273.261 ;Primary end point(s): - mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Value of Neutralizing Antibody Against COVID-19 Variants - mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Geometric Mean Fold Rise of Neutralizing Antibody Against COVID-19 Variants - mRNA-1273.251 and mRNA-1273.261: Seroresponse Rate;Timepoint(s) of evaluation of this end point: - Up to Day 29 - Up to 28 days after last dose of study intervention - Up to Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - mRNA-1273.251: Geometric Mean Titer of Neutralizing Antibody Against COVID-19 Variants of Participants =12 to <65 Years Old and =65 Years Old - mRNA-1273.167, mRNA-1273.712, mRNA-1273.251, and mRNA-1273.261: Number of Participants with Serious Adverse Events, Adverse Events (AEs) Leading to Study Withdrawal, and AEs of Special Interest - mRNA-1273.251: Number of Participants with Solicited Local and Systemic Adverse Reactions - mRNA-1273.251 and mRNA-1273.261: Number of Participants with Unsolicited AEs;Timepoint(s) of evaluation of this end point: - Day 29 - Day 1 through end of study (up to Day 209) - Day 1 through 7 days after last dose of study intervention - Day 1 through 28 days after last dose of study intervention | — |
Countries
United States
Contacts
Public ContactModerna WeCare Team
ModernaTX, Inc.
Outcome results
None listed