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This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose | Experimental | hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22 |
|
| Cohort 2 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose | Experimental | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22 |
|
| Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose | Experimental | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1 |
|
| Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP per dose | Experimental | hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hAd5-S-Fusion+N-ETSD vaccine | Biological | The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Medically Attended Adverse Events (MAAE) | Number of Participants with MAAEs through 1 week post final vaccine administration | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
| Number of Participants With Solicited Local Reactogenicity AEs | Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
| Number of Participants With Solicited Systemic Reactogenicity AEs | Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
| Number of Participants With Unsolicited AEs | Number of Participants with unsolicited AEs through 1 week post final vaccine administration | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
| Number of Participants With Medically Attended Adverse Events (MAAE) | Number of Participants with MAAEs through 30 days post final vaccine administration | From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. |
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Inclusion Criteria
1. Are you sexually abstinent? 2. Are you in a mutually monogamous relationship with a known HIV-uninfected partner? 3. Have you had only one partner in the preceding 12 months who is believed to be HIV-uninfected and with whom condoms were used regularly?
Laboratory Inclusion Values/ Results:
10. Alanine aminotransferase (ALT) <1.1 times the upper limit of normal 11. Serum Creatinine <80 umol/L in females and <106 umol/L in males 12. Haemoglobin >12.0g/dL in females and >13.5g/dL in males 13. Platelets >150 x 109/L in all participants 14. No serological evidence of chronic infection with Hepatitis B (hepatitis B surface antigen (HepBSAg) negative by a locally approved assay) done during the screening period 15. No serological evidence of chronic infection with Hepatitis C (hepatitis C antibody(anti-HCV) negative by a locally approved assay) done during the screening period 16. Negative for SARS-CoV-2 (qPCR test) on NP swab(or other appropriate respiratory specimen) within 3 days prior to the first study vaccination 17. No serological evidence of prior infection with SARS-CoV-2 (by a locally approved assay) done during the screening period 18. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female participant.
19. Negative for HIV-1 and -2 on blood test(by either 2 rapid tests or an ELISA, both must be locally approved assays) done during the screening period.
Reproductive Status:
20. Female participants of childbearing potential must agree to use effective contraception for sexual activity that may lead to pregnancy while on study until at least 30 days after the last dose of the study vaccine. Effective contraception for female participants includes:
Or; 22. Participant must not be of reproductive potential or sterile(as verified by medical records), such as:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khayelitsha Clinical Research Site | Khayelitsha | 7784 | South Africa |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose | hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| FG001 | Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| FG002 | Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| FG003 | Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose | hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (n = 10): hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) Per Dose | hAd5-S-Fusion+N-ETSD at 5 × 10e10 Viral Particles (VP) per dose on Days 1 and 22 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| 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 With Medically Attended Adverse Events (MAAE) | Number of Participants with MAAEs through 1 week post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
|
Solicited AEs: From first dose to 1 week post final vaccine; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. Unsolicited AEs: From first dose to 30 days post final vaccine; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. Medically Attended AEs and Serious AEs: From first dose to 6 months post final vaccine; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. SAEs related to treatment were reported any time, up to 1 year.
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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 | Group 1: Cohort 1 | Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | Systematic Assessment |
Cohort 4 (sublingual 1x10e11 VP per dose on Day 1) and Cohort 5 (sublingual and subcutaneous 1x10e11 VP for each dose on Day 1) did not enroll any subjects.
Only one AE table per AE category was presented to reduce data entry redundancy.
Only safety data is provided due to low enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lennie Sender, Chief Operating Officer | Immunitybio | 855-797-9277 | lennie.sender@immunitybio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 6, 2021 | Apr 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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|
| Number of Participants With Unsolicited AEs |
Number of Participants with unsolicited AEs through 30 days post final vaccine administration |
| From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. |
| Number of Participants With Medically Attended Adverse Events (MAAE) | Number of Participants with MAAEs through 6 months post final vaccine administration | From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. |
| Number of Participants With Unsolicited AEs | Number of Participants with unsolicited AEs through 6 months post final vaccine administration | From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. |
| BG001 | Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| BG002 | Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| BG003 | Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose | hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cohorts 1 and 2 SARS-CoV-2 seronegative healthy volunteers | Count of Participants | Participants |
|
| Cohorts 3 and 6 SARS-CoV-2 seropositive healthy volunteers | Count of Participants | Participants |
|
| OG001 |
| Cohort 2 (n = 11): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose |
hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose on Days 1 and 22 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| OG002 | Cohort 3 (n = 10): hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP Per Dose | hAd5-S-Fusion+N-ETSD at 1 × 10e11 VP per dose (or 5 × 10e10 VP per dose if safety concerns identified at higher dose) on Day 1 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
| OG003 | Cohort 6 (n=10):hAd5-S-Fusion+N-ETSD at 4 × 10e10 VP Per Dose | hAd5-S-Fusion+N-ETSD at 2 × 10e10 VP per nostril (or 4 × 10e10 VP per dose) on Day 1 hAd5-S-Fusion+N-ETSD vaccine: The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity. |
|
|
| Primary | Number of Participants With Solicited Local Reactogenicity AEs | Number of Participants with solicited local reactogenicity AEs through 1 week post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
|
|
|
| Primary | Number of Participants With Solicited Systemic Reactogenicity AEs | Number of Participants with solicited systemic reactogenicity AEs through 1 week post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
|
|
|
| Primary | Number of Participants With Unsolicited AEs | Number of Participants with unsolicited AEs through 1 week post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 1 week post final vaccine administration; up to 29 days for Cohorts 1 and 2, and up to 8 days for Cohorts 3 and 6. |
|
|
|
| Primary | Number of Participants With Medically Attended Adverse Events (MAAE) | Number of Participants with MAAEs through 30 days post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. |
|
|
|
| Primary | Number of Participants With Unsolicited AEs | Number of Participants with unsolicited AEs through 30 days post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 30 days post final vaccine administration; up to 52 days for Cohorts 1 and 2 and up to 31 days for Cohorts 3 and 6. |
|
|
|
| Primary | Number of Participants With Medically Attended Adverse Events (MAAE) | Number of Participants with MAAEs through 6 months post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. |
|
|
|
| Primary | Number of Participants With Unsolicited AEs | Number of Participants with unsolicited AEs through 6 months post final vaccine administration | Posted | Count of Participants | Participants | From first dose of study treatment through 6 months post final vaccine administration; up to 202 days for Cohorts 1 and 2, and up to 181 days for Cohorts 3 and 6. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | Group 1: Cohort 2 | Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 11 | 0 | 11 | 5 | 11 |
| EG002 | Group 1: Cohort 3 | Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 7 | 10 |
| EG003 | Group 1: Cohort 6 | Incidence of Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 2 | 10 |
| EG004 | Group 2: Cohort 1 | Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 6 | 10 |
| EG005 | Group 2: Cohort 2 | Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 11 | 0 | 11 | 5 | 11 |
| EG006 | Group 2: Cohort 3 | Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 6 | 10 |
| EG007 | Group 2: Cohort 6 | Incidence of Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 4 | 10 |
| EG008 | Group 3: Cohort 1 | Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 5 | 10 |
| EG009 | Group 3: Cohort 2 | Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 11 | 0 | 11 | 9 | 11 |
| EG010 | Group 3: Cohort 3 | Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 4 | 10 |
| EG011 | Group 3: Cohort 6 | Incidence of Unsolicited Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 6 | 10 |
| EG012 | Group 4: Cohort 1 | Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 2 | 10 |
| EG013 | Group 4: Cohort 2 | Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 11 | 0 | 11 | 3 | 11 |
| EG014 | Group 4: Cohort 3 | Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 2 | 10 |
| EG015 | Group 4: Cohort 6 | Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration | 0 | 10 | 0 | 10 | 4 | 10 |
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site reaction | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| HIV infection | Infections and infestations | Systematic Assessment |
|
| Impetigo | Infections and infestations | Systematic Assessment |
|
| Oral herpes | Infections and infestations | Systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Phlebitis | Vascular disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Asymptomatic COVID-19 | Infections and infestations | Systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Injection site bruising | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Eye contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |