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 SARS-CoV-2) |
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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 days with severe respiratory infectious diseases at hospital and/or at home in elderly subjects during the pandemic of SARS-CoV-2 |
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E.2.2 | Secondary objectives of the trial |
To assess the reduction of disease severity, the duration of hospital admission, intensive care unit (ICU) admission, or death in elderly subjects during the pandemic of SARS-CoV-2 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female adult (≥ 60 years) 2. Subject is contractually capable, able to understand information on study and has signed informed consent sheet 3. Subject has access to an internet-enabled electronic device |
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E.4 | Principal exclusion criteria |
1. Known active or latent Mycobacterium tuberculosis infection 2. Fever (> 38 °C) or respiratory tract infection within the past 24 hours 3. Current active viral or bacterial infection 4. Expected vaccination during the study period; vaccinations against influenza and pneumococcal disease are allowed with ≥ 4 weeks between these vaccinations and the trial vaccination 5. Participation in another interventional study within 30 days before screening and during this study 6. Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior Bacille Calmette-Guérin (BCG) administration 7. Severely immunocompromised subjects, including: (a) subjects with known infection by the human immunodeficiency virus (HIV-1); (b) subjects with solid organ transplantation; (c) subjects with bone marrow transplantation; (d) subjects under chemotherapy, immunotherapy, or 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, or likely use of oral or intravenous steroids in the next 4 weeks; 8. History of malignancies, unless the subject has been free of the disease for ≥ 2 years; exception: subjects with adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer and adequately treated carcinoma in situ of the cervix may participate in the trial 9. Previous positive SARS-CoV-2 test result 10. Person is an employee of the sponsor, a relative of the sponsor or investigator, or is employed in the same department as the investigator |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of days with severe respiratory disease at hospital and/or at home |
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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 hospital admissions • Cumulative incidence of documented SARS-CoV-2 infection • Number of days with self-reported fever (≥ 38 ºC) • Number of days with 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 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 | 20 |
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 |
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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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |