Part B (Blinded): mRNA-1273 at Month 6 vs Part B (Blinded): mRNA-1273.222 at Month 6: Part B: Number of Participants With Serious Adverse Events (SAEs)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0189 | 0.0165 | 0.0215 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0224 | 0.0168 | 0.0298 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00351 | -0.0113 | 0.00271 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.843 | 0.613 | 1.16 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.84 | 0.607 | 1.16 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Part B (Blinded): mRNA-1273 at Month 6 than on Part B (Blinded): mRNA-1273.222 at Month 6 | 285 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Part B (Blinded): mRNA-1273 at Month 6 | Received monovalent booster at Month 6 | 212 | 11,243 | OG000 | ClinicalTrials.gov |
| Group 2 | Part B (Blinded): mRNA-1273.222 at Month 6 | Received bivalent booster at Month 6 | 45 | 2,012 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Part B: Number of Participants With Serious Adverse Events (SAEs) | ClinicalTrials.gov |
| Description | An SAE is any AE that results in any of the following outcomes: death, a life-threatening adverse event, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, congenital anomaly/birth defect, or is medically important. | ClinicalTrials.gov |
| Time frame | Day of Month 6 vaccination up to Month 18 | ClinicalTrials.gov |
| Population | Participants who received a Month 6 vaccination, regardless of in or outside the randomization scheme, and with solicited and unsolicited AEs collected (FM6 cohort). | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern | ClinicalTrials.gov |
| NCT number | NCT05168813 | ClinicalTrials.gov |
| Phases | PHASE2, PHASE3 | ClinicalTrials.gov |
| Conditions | SARS-CoV-2 Infection, HIV Infections, COVID-19 | ClinicalTrials.gov |
| Interventions | Moderna mRNA-1273, Moderna mRNA-1273.222, Vaccine 3 Dose, Vaccine 2 Dose | ClinicalTrials.gov |
| Lead sponsor | COVID-19 Prevention Network | ClinicalTrials.gov |
| Results first posted | 2025-11-26 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05168813?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.