E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Coronavirus disease 2019 (COVID-19) |
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E.1.1.1 | Medical condition in easily understood language |
Coronavirus disease 2019 (COVID-19) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 |
Comparative effect over time on the immune response of approved COVID-19 vaccines used in mass vaccination in Sweden |
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E.2.2 | Secondary objectives of the trial |
• Immune response in people with a history of covid-19 infection. • Immune response after the first dose • Immune response after the second dose (for vaccines given with two doses) • Difference in immune response between different vaccine types • Immune response in subpopulations (e.g. elderly (70+) and gender) • Immune response in those who have undergone covid-19 infection without developing antibodies • Immune response over time |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
This study is a sub-study in the: COVID-Vaccination Effectiveness, Risk and Safety study - COVERS. This project was approved by the Swedish Ethichal Review Authority on 27-Jan-2021. The other parts of the Main study are non-interventional and thus not included in this application. |
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E.3 | Principal inclusion criteria |
1. To be included, the person must have received the COVID-19 vaccine. 2. To be included, the person must, in addition to vaccination against COVID-19, also have a) signed by EPM approved participant information b) reached the age of 18. |
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E.4 | Principal exclusion criteria |
Subjects below the age of 18 are excluded |
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E.5 End points |
E.5.1 | Primary end point(s) |
Serology against COVID-19 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The serology against COVID-19 will be evaluated in conjunction to the vaccination and 1, 6, 12 och 24 monts after. |
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E.5.2 | Secondary end point(s) |
Follow-ups of immunity and self-reported side effects a) What proportion becomes immune after vaccination? b) How long does antibody-mediated, cellular and local immunity remain after vaccination? |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The serology against COVID-19 will be evaluated in conjunction to the vaccination and 1, 6, 12 och 24 monts after. |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |