E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy volunteers, senior citizens of 65 years or older. Immune system activation after BCG vaccination. Acute infections, COVID-19 and self-reported respiratory illness will be monitored. |
|
E.1.1.1 | Medical condition in easily understood language |
Healthy volunteers, senior citizens of 65 years or older. Effect of BCG vaccination on the immune system. Acute infections, COVID-19 and self-reported respiratory illness will be monitored. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084382 |
E.1.2 | Term | Coronavirus disease 2019 |
E.1.2 | System Organ Class | 100000004862 |
|
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 |
Primary objective: To reduce senior citizens’ risk of acute infection during the COVID-19 pandemic. |
|
E.2.2 | Secondary objectives of the trial |
Secondary objectives: To reduce senior citizens’ risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens’ risk of self-reported respiratory illness during the COVID-19 pandemic. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet the following criteria: ≥65 years old. |
|
E.4 | Principal exclusion criteria |
A potential subject who meets any of the following criteria will be excluded from participation in this study: • Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration • Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species • Previous confirmed COVID-19 infection • Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection • Vaccination with other live attenuated vaccine within the last 4 weeks • Subjects who do not have access to e-Boks • Severely immunocompromised subjects. This exclusion category comprises: • Subjects with known infection with human immunodeficiency virus (HIV) • Subjects with solid organ transplantation or bone marrow transplantation • Subjects under chemotherapy • Subjects with primary immunodeficiency • Treatment with any anti-cytokine therapy within the last year • 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 within the prior two years |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is acute infection identified either by a doctor, antibiotics use, hospitalization or death due to infection.
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Secondary outcomes are verified SARS-CoV-2 infection and self-reported respiratory illness. Supplementary analyses will explore the effect of the intervention on severity of any SARS-CoV-2 infection. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
|
End of trial is defined as whichever comes latest: the last patient's last registration in the online data collection, or 365 days. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |