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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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This study aims to evaluate the safety (in all participants) and reactogenicity (in a subset of participants) of CVnCoV administered as a 2-dose schedule to adult participants 18 years of age or older. The study also aims to assess antibody responses to the receptor-binding domain (RBD) of spike (S) protein of SARS-CoV-2 after 1 and 2 doses of CVnCoV in adults 18 years of age or older included in a subset of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVnCoV: Group 1, Lot 1 | Experimental | Participants in Group 1 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| CVnCoV: Group 2, Lot 2 | Experimental | Participants in Group 2 will be vaccinated with CVnCoV 12 µg mRNA on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| Placebo | Placebo Comparator | Participants will receive a placebo on Day 1 and Day 29 in the deltoid area, preferably in the non-dominant arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVnCoV Vaccine | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2 | Medically attended AEs were defined as AEs with medically attended visits that are 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. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Up to 6 months after Dose 2 (Days 29 to 211) |
| Number of Participants Who Experienced a Serious Adverse Event (SAE) | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Day 1 to Day 393 |
| Intensity of SAEs Per the Investigator's Assessment | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
| Day 1 to Day 393 |
| Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Neutralizing activity of induced antibodies was determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 neutralizing antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. |
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Inclusion Criteria:
Male or female participants 18 years of age or older.
Health care workers (HCWs), employees or students in clinical training.
Provide written informed consent prior to initiation of any trial procedures.
Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.
Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening [Day 1] without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status.
Females of childbearing potential: negative urine pregnancy test (human chorionic gonadotropin within 24 hours prior to each trial vaccination on Day 1 and Day 29.
Females of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin der Johannes-Gutenberg-Universität Mainz Langenbeckstr. 1 | Mainz | 55131 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39040887 | Derived | Kowalzik F, Teschner D, Mesquita M, Jensen C, Schreiner D, Kronfeld K, Tubic-Grozdanis M, Cheatham-Seitz D, Hettich F, Quintini G, Schoenborn-Kellenberger O, Codo P, von Eisenhart-Rothe P, Mann P, Oostvogels L, Gehring S. A phase 3, randomised, observer-blinded, placebo controlled-trial evaluating the safety and immunogenicity of investigational SARS-CoV-2 mRNA vaccine CVnCoV in adult healthcare workers in Mainz (Germany). Vaccine X. 2024 Jun 20;19:100512. doi: 10.1016/j.jvacx.2024.100512. eCollection 2024 Aug. |
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Of the 2357 participants who were randomized, 2351 participants were treated.
This trial was performed in Germany between 23 December 2020 and 08 June 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | CVnCoV: Group 1, Lot 1 | Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| FG001 | CVnCoV: Group 2, Lot 2 | Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| FG002 | Placebo | Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
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| ID | Title | Description |
|---|---|---|
| BG000 | CVnCoV: Group 1, Lot 1 | Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| BG001 | CVnCoV: Group 2, Lot 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced a Medically Attended Adverse Event (AE) Occurring in the Following 6 Months After Dose 2 | Medically attended AEs were defined as AEs with medically attended visits that are 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. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Up to 6 months after Dose 2 (Days 29 to 211) |
|
Day 1 to Day 393
Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CVnCoV: Group 1, Lot 1 | Participants in Group 1 were vaccinated with CVnCoV 12 µg Lot 1 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Information | CureVac SE | 0049 6976805870 | clinicaltrials@curevac.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 22, 2021 | Nov 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 8, 2022 | Nov 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| D045169 | Severe Acute Respiratory Syndrome |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C000722934 | CVnCoV COVID-19 vaccine |
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| Placebo | Drug | Intramuscular injection |
|
The following events were considered and collected as AESI throughout the trial:
The Investigator assessed the relationship between trial vaccine and occurrence of each AE. |
| Up to 1 year after Dose 2 (Days 29 to 393) |
| Number of Participants Who Experienced Death Due to SAE | An SAE was defined as any untoward medical occurrence that, at any dose:
| Day 1 to Day 393 |
| Number of Participants Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2 | Up to 1 year after Dose 2 (Days 29 to 393) |
| Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2 | Up to 1 year after Dose 2 (Days 29 to 393) |
| Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Day 1 to 28 days after Dose 2 (Day 57) |
| Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
| Day 1 to 28 days after Dose 2 (Day 57) |
| Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme-linked immunosorbent assay (ELISA). Percentage with 95% confidence interval (CI) of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 Spike Protein RBD IgG antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Baseline (Day 1), Day 29 and Day 43 |
| SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA and expressed as geometric mean of titers (GMT) with 95% CI, by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Day 1, Day 29 and Day 43 |
| Baseline (Day 1), Day 29 and Day 43 |
| SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43 | Neutralizing activity of induced antibodies was determined by an activity assay. GMT with 95% CI of SARS-CoV-2 neutralizing antibody levels is presented by group. Individual values below the LLOQ were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Day 1, Day 29 and Day 43 |
| Physician Decision |
|
| Withdrawal by Participant |
|
| Lost to Follow-up |
|
| Miscellaneous |
|
| Did Not Receive Treatment |
|
Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29.
| BG002 | Placebo | Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | CVnCoV: Group 2, Lot 2 | Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
| OG002 | Placebo | Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. |
|
|
| Primary | Number of Participants Who Experienced a Serious Adverse Event (SAE) | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
|
|
| Primary | Intensity of SAEs Per the Investigator's Assessment | An SAE was defined as any untoward medical occurrence that, at any dose:
The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
| Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
|
|
| Primary | Number of Participants Who Experienced an Adverse Event of Special Interest (AESI) Occurring in the Following 1 Year After Dose 2 | The following events were considered and collected as AESI throughout the trial:
The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Up to 1 year after Dose 2 (Days 29 to 393) |
|
|
|
| Primary | Number of Participants Who Experienced Death Due to SAE | An SAE was defined as any untoward medical occurrence that, at any dose:
| Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Day 1 to Day 393 |
|
|
|
| Primary | Number of Participants Who Experienced an AE Leading to Vaccine Withdrawal Occurring in the Following 1 Year After Dose 2 | Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Up to 1 year after Dose 2 (Days 29 to 393) |
|
|
|
| Primary | Number of Participants Who Experienced an AE Leading to Trial Discontinuation Occurring in the Following 1 Year After Dose 2 | Safety Analysis Set: All participants randomized in the trial who received at least one dose of any lot of CVnCoV or placebo vaccine. | Posted | Count of Participants | Participants | Up to 1 year after Dose 2 (Days 29 to 393) |
|
|
|
| Primary | Number of Participants Who Experienced an Unsolicited AE Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator assessed the relationship between trial vaccine and occurrence of each AE. | Safety Analysis Subset: The first 1289 participants enrolled who belong to the Safety Analysis Set. | Posted | Count of Participants | Participants | Day 1 to 28 days after Dose 2 (Day 57) |
|
|
|
| Primary | Intensity of Unsolicited AEs Per the Investigator's Assessment Occurring on the Day of Vaccination and the Following 28 Days After Any Dose | eDiaries were used for the collection of unsolicited AEs on each vaccination day and the following 28 days. The Investigator made an assessment of intensity for each AE reported during the trial and assigned it to one of the following categories:
| Safety Analysis Subset: The first 1289 participants enrolled who belong to the Safety Analysis Set. | Posted | Count of Participants | Participants | Day 1 to 28 days after Dose 2 (Day 57) |
|
|
|
| Primary | Occurrence of Seroconversion for SARS-CoV-2 Receptor-Binding Domain (RBD) of Spike Protein Antibodies (IgG) on Day 29 and Day 43 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by enzyme-linked immunosorbent assay (ELISA). Percentage with 95% confidence interval (CI) of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 Spike Protein RBD IgG antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1), Day 29 and Day 43 |
|
|
|
| Primary | SARS-CoV-2 RBD of Spike Protein Antibody (IgG) Levels on Days 1, 29 and 43 | Titers of IgG antibodies directed against the SARS-CoV-2 RBD of Spike Protein antigen were measured by ELISA and expressed as geometric mean of titers (GMT) with 95% CI, by group. Individual values below the lower limit of quantification (LLOQ) were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included. | Posted | Geometric Mean | 95% Confidence Interval | GMT | Day 1, Day 29 and Day 43 |
|
|
|
| Secondary | Occurrence of Seroconversion for SARS-CoV-2 Neutralizing Antibodies on Day 29 and Day 43 | Neutralizing activity of induced antibodies was determined by an activity assay. Percentage with 95% CI of participants for whom a seroconversion was observed is presented by group. Seroconversion was defined as a fold increase above 1 in SARS-CoV-2 neutralizing antibody levels in participants seronegative at Baseline. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Day 1), Day 29 and Day 43 |
|
|
|
| Secondary | SARS-CoV-2 Neutralizing Antibody Levels on Days 1, 29 and 43 | Neutralizing activity of induced antibodies was determined by an activity assay. GMT with 95% CI of SARS-CoV-2 neutralizing antibody levels is presented by group. Individual values below the LLOQ were set to half of the LLOQ. Participants who tested positive for COVID-19 had their data included up to the point of a positive test result. Participants who received a licensed/authorized vaccine were censored at the day after receiving the licensed/authorized vaccine. | Per Protocol Immunogenicity Set: 250 participants who received both doses as randomized and within the windows defined in the protocol, had no major protocol deviations expected to impact the immunogenicity outcomes, and had not received medical treatments that may interfere with any of the immunogenicity measurements. Only participants seronegative at Baseline with evaluable samples at each visit are included. | Posted | Geometric Mean | 95% Confidence Interval | GMT | Day 1, Day 29 and Day 43 |
|
|
|
| 0 |
| 783 |
| 8 |
| 783 |
| 542 |
| 783 |
| EG001 | CVnCoV: Group 2, Lot 2 | Participants in Group 2 were vaccinated with CVnCoV 12 µg Lot 2 as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. | 0 | 785 | 10 | 785 | 547 | 785 |
| EG002 | Placebo | Participants received a placebo as an intramuscular injection by needle in the deltoid area on Day 1 and Day 29. | 1 | 783 | 6 | 783 | 475 | 783 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Small intestine gangrene | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Ganglioglioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| D007239 |
| Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Any severe SAEs |
|
| Title | Measurements |
|---|---|
|
|
|
| Any severe unsolicited AEs |
|
| Any unsolicited AEs without intensity assessment |
|
|
| Day 43 |
|
|
|
| Day 29 |
|
|
| Day 43 |
|
|
|
| Day 43 |
|
|
|
| Day 29 |
|
|
| Day 43 |
|
|