COVID-19
Conditions
Keywords
mRNA-1283.222, mRNA-1273.222, mRNA-1283.815, mRNA-1273.815, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Brief summary
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
Interventions
BIOLOGICALmRNA-1283.222
Sterile liquid for injection
BIOLOGICALmRNA-1273.222
Sterile liquid for injection
BIOLOGICALmRNA-1283.815
Sterile liquid for injection
BIOLOGICALmRNA-1273.815
Sterile liquid for injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * 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. Key
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 degrees Celsius \[°C\]/100.4 degrees 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 milligrams (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. Note: Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Day 1 to end of study (EOS) (Day 365) | — |
| Parts 1 and 2: rVE of mRNA-1283 and mRNA-1273 (Variant Formulations) to Prevent the First Event of COVID-19 | From 14 days after injection to Day 365 | The rVE is defined as the percent of reduction in the hazards of the first occurrence of COVID-19 (mRNA-1283 vs. mRNA-1273) starting 14 days after the booster dose. |
| Part 1: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 7 (7-day follow-up after vaccination) | — |
| Part 2: Number of Participants with Solicited Local and Systemic Reactogenicity ARs in Adolescents and Previously Unvaccinated Participants | Up to Day 7 (7-day follow-up after vaccination) | — |
| Parts 1 and 2: Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 28 (28-day follow-up after vaccination) | — |
| Part 1: Geometric Mean Ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 Over the Omicron BA.4/5 mRNA-1273.222 | Day 29 | — |
| Part 1: Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 | Day 29 | Seroresponse at the participant level is defined as an antibody value change from baseline below the lower limit of quantification (LLOQ) to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and \<4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ. |
| Part 1: GMR of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G mRNA-1283.222 Over the Ancestral SARS-CoV-2 D614G mRNA-1273.222 | Day 29 | — |
| Part 1: SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 | Day 29 | Seroresponse at the participant level is defined as an antibody value change from baseline below the LLOQ to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and \<4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G | Days 29, 91, 181, and 365 | Seroresponse at the participant level is defined as an antibody value change from baseline below the LLOQ to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and \<4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ. |
| Parts 1 and 2: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) | From 14 days after injection to Day 365 | — |
| Part 2: Number of Participants with Severe COVID-19 | From 14 days after injection to Day 365 | — |
| Part 1: Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G | Days 91, 181, and 365 | — |
Countries
Canada, Japan, United Kingdom, United States
Outcome results
None listed