Trial · NCT04652102
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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 |
| PRIMARY | Phase 2b Participants Only: Intensity of Unsolicited AEs as Per Investigator Assessment | 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 |
| PRIMARY | Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation | 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 |
| SECONDARY | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Moderate to Severe Case of COVID-19 | Day 44 to Day 393 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Severe Case of COVID-19 | Day 44 to Day 393 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Day 44 to Day 393 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Aged ≥ 61 Who Experienced a First Episode of Virologically-confirmed (RT-PCR Positive) Case of COVID-19 of Any Severity | Day 44 to Day 393 | The EAS including only participants who were aged ≥ 61. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Burden of Disease (BoD) Score #1 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Day 44 to Day 393 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Day 44 to Day 393 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SARS-CoV-2 Receptor Binding Domain (RBD) of Spike (S) Protein Antibody Levels on Days 1, 29, 43, 120 and 211 | Days 1 (baseline), 29, 43, 120 and 211 | Per Protocol Immunogenicity (PPI) Set: Included all Phase 2b participants from the Immunogenicity Subset who received both doses as randomized and within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis. | titers | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Seroconverting to SARS-CoV-2 RBD of S Protein Antibodies on Days 29, 43, 120 and 211 | Baseline and Days 29, 43, 120 and 211 | PPI Set: Included all Phase 2b participants seronegative at baseline from the Immunogenicity Subset who received both doses as randomized \& within the specified windows, had no important protocol deviations that impacted immunogenicity outcomes, did not receive medical treatments that interfered with the proposed immunogenicity measurements and had at least one blood sample collected at baseline and starting at 14 days post-second vaccination available for analysis. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04652102/outcomes