CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity
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 | 0.00646 | 0.00521 | 0.008 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0119 | 0.0101 | 0.014 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.00542 | -0.00784 | -0.00307 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.544 | 0.416 | 0.712 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.541 | 0.413 | 0.709 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on CVnCoV 12 μg Vaccine than on Placebo | 185 | 128 | 326 | 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 | 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. | 83 | 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. | 145 | 12,211 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants Who Experienced a First Episode of Virologically-confirmed {Reverse Transcription Polymerase Chain Reaction (RT-PCR) Positive} Case of COVID-19 of Any Severity | ClinicalTrials.gov |
| Description | A case of COVID-19 meeting the definition for primary efficacy analysis was defined as follows:~* Virologically-confirmed case of COVID-19 (of any severity) defined as a positive SARS-CoV-2 specific RT-PCR test in a person with clinically symptomatic COVID-19.~* Symptom onset ≥ 15 days after second trial vaccination.~* First episode of virologically-confirmed COVID-19, i.e. the participant must not have had a history of virologically-confirmed COVID-19 illness at enrollment or have had developed a case of virologically-confirmed COVID-19 before 15 days after the second trial vaccination.~* Participant was SARS-CoV-2 naïve at baseline and Day 43 (defined as seronegative to N protein in the blood samples collected at baseline and Day 43).~* Primary efficacy cases were confirmed by an Adjudication Committee.~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 | Efficacy Analysis Set (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 \& 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 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.