Trial · NCT04652102
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
NCT04652102, Phase 2, Phase 3, Completed, CureVac; results first posted 2024-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04652102. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04652102
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT04652102
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 39,680 participants, actual
- Lead sponsor
- CureVac
- Conditions
- Covid19, SARS-CoV-2
- Interventions
- CVnCoV, Placebo, Authorized/licensed vaccines for preventing COVID-19 (AV) as standard of care through their national vaccination program
- First posted
- 2020-12-03
- Last updated
- 2024-04-29
- Other registries' IDs
- eudract:2020-003998-22
- Results first posted
- 2024-04-29
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Day 44 to Day 393 | 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. |
| Primary | Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | Day 1 to Day 211 | Medically-attended AEs were defined as AEs with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Clinic visits for COVID-19 testing resulting in negative test results were not considered as medically attended visits, if there is no confirmed diagnosis and no prescribed concomitant medication. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Number of Participants Who Experienced One or More Serious AE (SAE) | Day 1 to Day 393 | An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator assessed the relationship between trial vaccine and occurrence of each SAE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Intensity of SAEs as Per Investigator Assessment | Day 1 to Day 393 | An SAE was defined as any untoward medical occurrence that, at any dose: * Resulted in death. * Was life-threatening. * Required inpatient hospitalization or prolongation of existing hospitalization. * Resulted in persistent disability/incapacity. * Was a congenital anomaly/birth defect in the offspring of the participant. * Was an important medical event. The Investigator made an assessment of intensity of each SAE reported during the trial. Each SAE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI) | Day 1 to Day 393 | AESIs included: * AEs with a suspected immune-medicated etiology. * Other AEs relevant to SARS-CoV-2 vaccine development or the target disease. The Investigator assessed the relationship between trial vaccine and occurrence of each AESI. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Number of Participants Who Experienced a Fatal SAE | Day 1 to Day 393 | A fatal SAE was defined as an SAE that resulted in death. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. The Investigator made an assessment of intensity of each solicited AE reported during the trial. Each solicited AE was graded from Mild (Grade 1) to Severe (Grade 3), where higher grades indicated a worse outcome. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Phase 2b Participants Only: Duration of Solicited AEs | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) | Solicited local AEs (injection site pain, redness, swelling, and itching) and solicited systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) were recorded on the day of vaccination and the following 7 days using an eDiary. Duration is calculated as consecutive days with a respective solicited AE regardless of the grade of the AE. AEs ongoing after Day 8 are included. In each case only the longest consecutive duration is displayed. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Primary | Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | eDiaries were used for collection of unsolicited AEs on each vaccination day and the following 28 days. In addition, participants received a prompt (by e.g., a phone call or text message) to verify whether the participants had any health concerns since the last visit. The Investigator assessed the relationship between trial vaccine and each occurrence of each AE. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Day 44 to Day 393 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | Day 1 to Day 211 | Safety Analysis Set (SAS): Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced One or More Serious AE (SAE) | Day 1 to Day 393 | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Intensity of SAEs as Per Investigator Assessment | Day 1 to Day 393 | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. Only participants who experienced SAEs were included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced One or More Adverse Event of Special Interest (AESI) | Day 1 to Day 393 | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Experienced a Fatal SAE | Day 1 to Day 393 | SAS: Included all participants randomized in Phase 2b or 3 who received at least one dose of CVnCoV or placebo. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2b Participants Only: Number of Participants Who Experienced One or More Solicited AE | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) | The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2b Participants Only: Intensity of Solicited AEs as Per Investigator Assessment | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) | The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. Only participants who experienced solicited AEs were included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase 2b Participants Only: Duration of Solicited AEs | Up to 7 days after vaccination (Days 1 to 7 and Days 29 to 36) | The SASsol: Included all phase 2b participants of the SAS with at least one diary collection indicating the occurrence or lack of occurrence of solicited AEs. Only participants who experienced solicited AEs were included. | days | MEAN |
| PRIMARY | Phase 2b Participants Only: Number of Participants Who Experienced One or More Unsolicited AE | Up to 28 days after vaccination (Days 1 to 29 and Days 29 to 57) | SAS 2: Included all Phase 2b participants of the SAS. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | CVnCoV 12 μg Vaccine | 83 | Participants | ||
| 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 | Placebo | 145 | Participants | ||
| Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | CVnCoV 12 μg Vaccine | Any Medically-attended AE | 2555 | Participants | |
| Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | Placebo | Any Medically-attended AE | 2084 | Participants | |
| Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | CVnCoV 12 μg Vaccine | Any Related Medically-attended AE | 505 | Participants | |
| Number of Participants Who Experienced One or More Medically-attended Adverse Events (AE) | Placebo | Any Related Medically-attended AE | 138 | Participants | |
| Number of Participants Who Experienced One or More Serious AE (SAE) | CVnCoV 12 μg Vaccine | Any SAE | 149 | Participants | |
| Number of Participants Who Experienced One or More Serious AE (SAE) | Placebo | Any SAE | 111 | Participants | |
| Number of Participants Who Experienced One or More Serious AE (SAE) | CVnCoV 12 μg Vaccine | Any Related SAE | 8 | Participants | |
| Number of Participants Who Experienced One or More Serious AE (SAE) | Placebo | Any Related SAE | 1 | Participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CVnCoV 12 μg Vaccine | 19,787 | |
| Overall Study | STARTED | Placebo | 19,753 | |
| Overall Study | Phase 2b Participants | CVnCoV 12 μg Vaccine | 2,007 | |
| Overall Study | Phase 2b Participants | Placebo | 1,987 | |
| Overall Study | Phase 3 Participants | CVnCoV 12 μg Vaccine | 17,780 | |
| Overall Study | Phase 3 Participants | Placebo | 17,766 | |
| Overall Study | Rolled Over to Open-Label Phase | CVnCoV 12 μg Vaccine | 8,513 | |
| Overall Study | Rolled Over to Open-Label Phase | Placebo | 0 | |
| Overall Study | COMPLETED | CVnCoV 12 μg Vaccine | 11,451 | |
| Overall Study | COMPLETED | Placebo | 4,161 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events432
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chills | General disorders | CVnCoV 12 μg Vaccine | 1,439 | 19,787 | 2,065 |
| other | Chills | General disorders | Placebo | 240 | 19,753 | 286 |
| other | Fatigue | General disorders | CVnCoV 12 μg Vaccine | 1,893 | 19,787 | 3,200 |
| other | Fatigue | General disorders | Placebo | 1,019 | 19,753 | 1,483 |
| other | Injection site pain | General disorders | CVnCoV 12 μg Vaccine | 2,008 | 19,787 | 3,231 |
| other | Injection site pain | General disorders | Placebo | 537 | 19,753 | 644 |
| other | Pyrexia | General disorders | CVnCoV 12 μg Vaccine | 1,305 | 19,787 | 1,700 |
| other | Pyrexia | General disorders | Placebo | 95 | 19,753 | 102 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | CVnCoV 12 μg Vaccine | 1,728 | 19,787 | 2,588 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Placebo | 509 | 19,753 | 634 |
1 to 10 of 432Source ClinicalTrials.gov
See all 432 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CVnCoV 12 μg Vaccine | 17 | 19,787 |
| Total, all-cause mortality | Placebo | 14 | 19,753 |
| Total, other adverse events | CVnCoV 12 μg Vaccine | 3,144 | 19,787 |
| Total, other adverse events | Placebo | 1,853 | 19,753 |
| Total, serious adverse events | CVnCoV 12 μg Vaccine | 149 | 19,787 |
| Total, serious adverse events | Placebo | 111 | 19,753 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34826381 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19 | Trial comparisons |
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 | Trial comparisons |
| CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Who Experienced a Fatal SAE | Trial comparisons |
| CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity | Trial comparisons |
| 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 | Trial comparisons |
| CVnCoV 12 μg Vaccine vs Placebo: deaths from any cause | Trial comparisons |
CVnCoV 12 μg Vaccine vs Placebo: Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity Due to Infection With Wild Type and Alpha SARS-CoV-2 Strains in SARS-CoV-2 Naïve Participants | Trial comparisons |
| CVnCoV 12 μg Vaccine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04652102
GET https://conductscience.org/api/trials/v1/NCT04652102/registered?page=2