Part A (Blinded): mRNA-1273 vs Part A (Blinded): Placebo: Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose
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 | 0.313 | 0.306 | 0.32 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.286 | 0.279 | 0.293 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0269 | 0.0165 | 0.0371 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.09 | 1.06 | 1.13 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.14 | 1.08 | 1.19 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Part A (Blinded): mRNA-1273 than on Part A (Blinded): Placebo | 37.2 | 26.9 | 60.4 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Part A (Blinded): mRNA-1273 | Participants received 100 μg mRNA-1273 on a 2-dose injection schedule (Day 1 and Day 29). | 4,752 | 15,184 | OG001 | ClinicalTrials.gov |
| Group 2 | Part A (Blinded): Placebo | Participants received mRNA-1273-matching placebo on a 2-dose injection schedule (Day 1 and Day 29). | 4,338 | 15,162 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Part A: Number of Participants With Unsolicited AEs up to 28 Days After Any Injection Dose | ClinicalTrials.gov |
| Description | Unsolicited AE was any AE reported by the participant that was not specified as an AR or was specified as a solicited AR in the protocol but started outside the protocol-defined, post-injection period for reporting solicited ARs. Unsolicited AEs were collected for the 28 days after any injection.~An AE was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A summary of all SAEs and all nonserious AEs (Other) reported up to the end of the study, regardless of causality, is located in the Reported Adverse Events section. | ClinicalTrials.gov |
| Time frame | Up to 28 days after any dose | ClinicalTrials.gov |
| Population | Safety Set: All randomized participants who received at least 1 dose. Participants were included in the treatment group corresponding to dose they actually received. For a participant who was randomized to placebo but received any dose of mRNA-1273 at any injection, the participant was included in the mRNA-1273 group in the Safety Set. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 | ClinicalTrials.gov |
| NCT number | NCT04470427 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | SARS-CoV-2 | ClinicalTrials.gov |
| Interventions | mRNA-1273, Placebo | ClinicalTrials.gov |
| Lead sponsor | ModernaTX, Inc. | ClinicalTrials.gov |
| Results first posted | 2024-03-21 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04470427?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.