CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19
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 | 0.000311 | 0.000121 | 0.0008 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.000819 | 0.000445 | 0.00151 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000508 | -0.00122 | 0.000108 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.38 | 0.119 | 1.21 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.38 | 0.119 | 1.21 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on CVnCoV 12 μg Vaccine than on Placebo | 1,970 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | CVnCoV 12 μg Vaccine | Participants in the Phase 2b and Phase 3 periods were vaccinated with CVnCoV 12 μg as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. | 4 | 12,851 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants in the Phase 2b and Phase 3 periods were vaccinated with matching placebo as an intramuscular injection by needle in the deltoid area, preferably in the non-dominant arm, on Day 1 and Day 29. | 10 | 12,211 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19 | ClinicalTrials.gov |
| Description | Severe COVID-19 cases were defined by any one of the following:~* Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at sea level or PaO2/FIO2 \< 300 mm Hg).~* Respiratory failure (defined as needing high flow-oxygen, noninvasive ventilation, mechanical ventilation or ECMO).~* Evidence of shock (SBP \< 90mm Hg, DBP \< 60 mmHg, or requiring vasopressors).~* Significant renal, hepatic, or neurologic dysfunction~* Admission to intensive care unit (ICU).~* Death.~Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. | ClinicalTrials.gov |
| Time frame | Day 44 to Day 393 | ClinicalTrials.gov |
| Population | EAS: All participants randomized in Phase 2b or Phase 3 who received both doses of trial vaccine, had not developed a virologically-confirmed case of COVID-19 before trial entry or before 15 days after the second vaccination, \& were SARS-CoV-2 naïve at baseline and Day 43. Participants must have not developed an asymptomatic case of SARS-CoV-2, not stopped the trial, not received an AV for preventing COVID-19 or not been unblinded prior to 15 days after the second vaccination. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older | ClinicalTrials.gov |
| NCT number | NCT04652102 | ClinicalTrials.gov |
| Phases | PHASE2, PHASE3 | ClinicalTrials.gov |
| Conditions | Covid19, SARS-CoV-2 | ClinicalTrials.gov |
| Interventions | CVnCoV, Placebo, Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program | ClinicalTrials.gov |
| Lead sponsor | CureVac | ClinicalTrials.gov |
| Results first posted | 2024-04-29 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT04652102?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.