Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05383560 | Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults | PHASE2 | COMPLETED | 179 | — | — | Sep 5, 2022 | Jan 31, 2024 | Feb 21, 2024 | 1 | Israel |
Safety of the study vaccines will be measured by solicited and unsolicited adverse injection site reactions and systemic reactions from the time of each vaccination through 7 days post each vaccination/placebo administrations. AEs will be collected up to 29 days after injection. Unsolicited non-serious AEs, SAEs, NOCMCs, and MAAEs will be collected through 6 months after the first vaccine dose.
Reactogenicity of the study vaccines will be measured by solicited and unsolicited adverse injection site reactions and systemic reactions from the time of each vaccination through 7 days post each vaccination/placebo administrations. AEs will be collected up to 29 days after injection. Unsolicited non-serious AEs, SAEs, NOCMCs, and MAAEs will be collected through 6 months after the first vaccine dose. The study will also assess reactogenicity using "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" Guide, via an electronic diary the participants would be required to complete every day for 7 consecutive days starting the day of each vaccine.
Primary immunogenicity outcome will be measured by changes in geometric titers (GMTs) and geometric fold raise (GMFRs) of IgG and neutralizing antibodies (nAb), using a pseudovirus assay during all visits. Blood for immunogenicity will be collected at all visits (total of 6 visits).
| Arm | Type | Description |
|---|---|---|
| mRNA-1273.214 + mRNA-1273.214 | EXPERIMENTAL | Fourth \& Fifth doses of an investigational mRNA vaccine, 56 days apart N ≈ 60 Under protocol versions 1.01-1.06 |
| mRNA-1273.214 + Placebo | EXPERIMENTAL | Fourth dose of an investigational mRNA vaccine followed by a fifth dose of placebo, 56 days apart N ≈ 60 Under protocol versions 1.01-1.06 |
| mRNA-1273 + Placebo | ACTIVE_COMPARATOR | Fourth dose of the commercial mRNA vaccine, followed by a fifth dose of placebo, 56 days apart N ≈ 30 Under protocol versions 1.01-1.06 |
| mRNA-1273.214 | EXPERIMENTAL | A booster dose of an investigational mRNA vaccine at Visit 1 (Day 1). N ≈ 30 Under protocol versions 1.07 |
| mRNA-1273.222 | ACTIVE_COMPARATOR | A booster dose of the commercial mRNA vaccine at Visit 1 (Day 1). N ≈ 30 Under protocol versions 1.07 |
| Name | Type | Description |
|---|---|---|
| mRNA-1273.214 Vaccine | BIOLOGICAL | Omicron Variant-Matched Vaccine |
| MRNA-1273 Vaccine | BIOLOGICAL | Moderna's commercial COVID-19 Vaccine |
| Placebo | BIOLOGICAL | Normal Saline for injection |
| MRNA-1273.222 Vaccine | BIOLOGICAL | Moderna's commercial COVID-19 Vaccine |
Inclusion Criteria: 1. Male or female participants 21 years of age, inclusively. 2. Protocol versions 1.01-1.06:Individuals who previously received mRNA primary series vaccination AND a booster dose at least 4 months prior to Day 1. Documented confirmation of prior mRNA series vaccination receipt m...