COVID-19
Conditions
Interventions
Product Name: mRNA-1283
Pharmaceutical Form: Injection
Product Name: mRNA-1273
Pharmaceutical Form: Injection
Sponsors
ModernaTX, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, at least 12 years of age at the time of consent (Screening Visit). - Investigator’s assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. - For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration. - Part 1: Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants =18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable. - Part 2: No prior vaccination is required. For participants who have been previously vaccinated, proof of vaccination is required. Are the trial subjects under 18? yes Number of subjects for this age range: 2000 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 21502 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10072
Exclusion criteria
Exclusion criteria: - Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days. - Participant is acutely ill or febrile (temperature =38.0 degree Celsius [°C]/100.4 degree Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1. - Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to Screening (for corticosteroids =10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. - Has received or plans to receive any licensed vaccine =60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection. - Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study. - Has donated =450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. - Has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of the mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2). ;Secondary Objective: - Part 1: To characterize the neutralizing antibody response against Omicron BA.4/5 and the ancestral SARS-CoV-2 D614G (1283.222 and 1273.222) at all timepoints. - Parts 1 and 2: To assess the incidence of SARS-CoV-2 infection regardless of symptoms (mRNA-1283 and mRNA-1273 [variant formulations]). - Part 2: To assess the incidence of severe COVID-19 (mRNA-1283.815 and mRNA-1273.815). ;Primary end point(s): 1. Part 1: Geometric Mean Ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 Over the Omicron BA.4/5 mRNA-1273.222 2. Part 1: Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 3. Part 1: GMR of the Ancestral SARS-CoV-2 D614G mRNA-1283.222 Over the Ancestral SARS-CoV-2 D614G mRNA-1273.222 4. Part 1: SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 5. Parts 1 and 2: rVE of mRNA-1283 and mRNA-1273 (variant formulations) to Prevent the First Event of COVID-19 6. Parts 1 and 2: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) 7. Parts 1 and 2: Number of Participants with Unsolicited Adverse Events (AEs) 8. Parts 1 and 2: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs);Timepoint(s) of evaluation of this end point: Primary endpoints 1 to 4: Day 29; Primary endpoint 5: From 14 days after injection to Day 365; Primary endpoint 6: Up to Day 7 (7-day follow-up after vaccination); Primary endpoint 7: Up to Day 28 (28-day follow-up after vaccination); Primary endpoint 8: Day 1 to end of study (EOS) (Day 365) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Part 1: Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G 2. Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G 3. Parts 1 and 2: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) 4. Part 2: Number of Participants with Severe COVID-19;Timepoint(s) of evaluation of this end point: Secondary endpoint 1: Days 91, 181, and 365; Secondary endpoint 2: Days 29, 91, 181, and 365 Secondary endpoints 3 and 4: From 14 days after injection to Day 365 | — |
Countries
Canada, United Kingdom, United States
Contacts
Public ContactClinical Trials Support Center
ModernaTX, Inc.
Outcome results
None listed