Trial · NCT04652102
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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. |
| 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) | 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 made an assessment of intensity of each unsolicited AE reported during the trial. Each unsolicited 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 | Number of Participants Who Experienced One or More AEs Leading to Vaccine Withdrawal or Trial Discontinuation | Day 1 to Day 393 | Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| 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 | Moderate cases defined by any 1 of the following: * Shortness of breath/difficulty breathing * Respiratory rate ≥20 to \<30 breaths per min * Abnormal SpO2 but still \>93% on room air at sea level * Clinical/radiographic evidence of lower respiratory tract disease * Radiologic evidence of DVT Severe cases defined by any 1 of the following: * Clinical signs at rest indicative of severe systemic illness (respiratory rate ≥ 30breaths 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 ICU * Death Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| 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 | 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. |
| 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 | The characterization of SARS-CoV-2 variants were implemented by viral whole genome sequencing of nasopharyngeal swab samples of participants followed by comparison with previously sequenced and typified genomes. The following phylogenetic clustering was applied: 1. "Wild type" virus: WT/D614G, lineages A.1/B.1 without the variant of concerns (VOCs) (i.e., without B.1.1.7 \[Alpha\], B.1.351 \[Beta\], B.1.429 \[Epsilon\]). 2. "UK" VOC: B.1.1.7 (Alpha). A case of COVID-19 was defined as follows: * Virologically-confirmed case of COVID-19 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 vaccination. * First episode of virologically-confirmed COVID-19. * Participant was SARS-CoV-2 naïve at baseline and Day 43. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| 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 | A case of COVID-19 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). Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| 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 | Score #1 was defined as no disease (not infected or asymptomatic infection) = 0; mild or moderate disease = 1; severe disease = 2. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| Secondary | BoD Score #2 Based on First Episodes of Virologically-confirmed (RT-PCR Positive) Cases of COVID-19 | Day 44 to Day 393 | Score #2 was defined as no disease (not infected or asymptomatic infection) = 0; disease without hospitalization = 1; disease with hospitalization = 2; death = 3. Participants were censored at the first day after unblinding or at the day after receiving the authorized/licensed vaccine, whichever was earlier. |
| 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 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme- linked immunosorbent assay (ELISA) and expressed as geometric mean of titers (GMT) with 95% confidence interval (CI), by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
| 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 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. In participants who tested seronegative to the N protein for SARS-CoV-2 at baseline, seroconversion was defined as a fold increase above 1 in antibody titer against SARS-CoV-2 RBD of S protein. Only participants seronegative at baseline with evaluable samples at each visit are included. Participants who tested positive for SARS-CoV-2 via PCR or N-protein antibodies had their data included up to the point of positive test result or symptom onset. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
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.
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