E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
infectious respiratory diseases (e.g. COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
Infectious diseases of the lung (e.g. COVID-19, which is caused by Coronavirus) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10024970 |
E.1.2 | Term | Respiratory tract infections |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the reduction of absenteeism among HCPs with direct patient contacts during the epidemic phase of COVID-19. |
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E.2.2 | Secondary objectives of the trial |
To assess the incidence of SARS-CoV-2 infection or symptoms of infection, reduction of hospital admission, ICU admission or death in HCPs with direct patient contacts during the epidemic phase of COVID-19. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult (≥18 years) • Male or female • Healthcare professionals taking care of potentially SARS-CoV-2 infected patients • Subject is contractually capable, able to understand information on study and has signed informed consent sheet • Subject has access to an internet-enabled electronic device • Women of childbearing potential (WOCBP) who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination. |
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E.4 | Principal exclusion criteria |
• Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior BCG administration • Known active or latent Mycobacterium tuberculosis infection or with another mycobacterial species. A history with or suspicion of M. tuberculosis infection. • Fever (>38 °C) within the past 24 hours • Pregnant or breast-feeding • Suspicion of active viral or bacterial infection • Participation of subject in another interventional study within 30 days before screening • Person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site • Severely immunocompromised subjects, such as: a) subjects with known infection with the human immunodeficiency virus (HIV); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy, immunotherapy and radiotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies; g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months • Active solid or non-solid malignancy or lymphoma in the past 5 years • Direct involvement in the design or the execution of the present clinical trial • Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc) • Employment of less than 50% a full-time equivalent • Previous positive SARS-CoV-2 test result |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Cumulative incidence of documented SARS-CoV-2 infection • Number of days absent from work due to documented SARS-CoV-2 infection Number of days absent from work due to exposure to person with documented SARS-CoV-2 infection • Number of days absent from work due to symptoms of respiratory disease, documented SARS-CoV-2 infection, or fever (≥ 38 °C) • Number of days of self-reported fever (≥38°C) • Number of days of self-reported acute respiratory symptoms • Cumulative incidence of self-reported acute respiratory symptoms • Cumulative incidence of death for any reason • Cumulative incidence of death due to documented SARS-CoV-2 infection • Cumulative incidence of ICU admission for any reason • Cumulative incidence of ICU admission due to documented SARS-CoV-2 infection • Cumulative incidence of hospital admission for any reason • Cumulative incidence of hospital admission due to documented SARS-CoV-2 infection |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |