E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination against COVID-19. |
Vaccination mot COVID-19. |
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E.1.1.1 | Medical condition in easily understood language |
Vaccination against COVID-19. |
Vaccination mot 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 |
To investigate the incidence of SARS-CoV-2 infections after vaccination, to monitor the development of SARS-CoV-2 antibody levels after vaccination and to compare this in relation to both previous health & disease, previous antibody responses and in relation to future disease occurring after vaccination.
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Att undersöka förekomsten av SARS-CoV-2-infektioner efter vaccination, att följa utvecklingen av SARS-CoV-2-antikroppsnivåer efter vaccination och jämföra detta i förhållande till både tidigare hälsa & sjukdom, tidigare antikroppssvar och i förhållande till framtida sjukdom som inträffar efter vaccination. |
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E.2.2 | Secondary objectives of the trial |
Not applicable. |
Inte tillämpbart. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Study participant who agreed to be included in the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County". • Study participant who has received or will receive vaccine against Covid-19 and who gives new written consent to the study “Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to on vaccinations”.
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• Forskningsperson som samtyckt till att ingå i studien ”Studier av pågående och genomgången SARS-CoV-2 infektion (som orsakar COVID-19) inom vård och omsorg i Stockholms län”. • Forskningsperson som fått eller kommer att få vaccin mot Covid-19 och som ger nytt skriftligt samtycke till studien” Studier av pågående och genomgången SARS-CoV-2 infektion (som orsakar COVID-19) inom vård och omsorg i Stockholms län, med avseende på vaccinationer”.
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E.4 | Principal exclusion criteria |
• those who have not given informed consent to participate in the study
In this study, no initiative is taken for vaccination. The vaccinations are carried out by the healthcare system and of course follow the established exclusion and inclusion criteria for the approved vaccines, the package leaflets of which are attached. All persons who have received the vaccine and who give written consent are eligible to be included in the study.
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• De som inte lämnat informerat samtycke till att delta i studien
I denna studie tas inget initiativ till vaccination. Vaccinationerna utförs av vården och följer självfallet de etablerade exklusions- och inklusionskriterierna för de godkända vaccinerna, vars bipacksedlar bifogas. Alla personer som fått vaccin och som ger skriftligt samtycke är valbara att ingå i studien. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the detection of SARS-CoV-2 infection, relative to whether vaccination has been given. SARS-CoV-2 infections will be characterized by whether they are asymptomatic infections or sick leave-requiring infections. Regarding possible side effects, the primary outcome measure is sick leave, which will be characterized regarding every known case of illness within the cohort.
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Primärt effektmått är påvisning av SARS-CoV-2 infektion, i förhållande till om vaccination givits. SARS-CoV-2 infektioner kommer att karakteriseras med avseende på om det är asymtomatiska infektioner eller sjukskrivningskrävande infektioner. Beträffande eventuella biverkningar så är det primära utfallsmåttet sjukskrivning, som kommer att karakteriseras beträffande varje i kohorten känt fall av sjukdom. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 months post primary vaccination. |
24 månader efter första vaccinationstillfället. |
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E.5.2 | Secondary end point(s) |
Secondary endpoint is induction of antibodies to SARS-CoV-2. These will be characterized in terms of antibody levels, which SARS-CoV-2 antigen to which the response is directed and whether the antibodies are protective or not. |
Sekundärt effektmått är induktion av antikroppar mot SARS-CoV-2. Dessa kommer att karakteriseras beträffande antikroppsnivåer, vilket SARS-CoV-2 antigen som svaret riktas mot samt om antikropparna är skyddande eller ej. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 months post primary vaccination. |
24 månader efter första vaccinationstillfället. |
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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 | No |
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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The study stops enrolling when participants in the cohort are no longer offered vaccination. Follow-up is planned to continue as long as there are still cases of SARS-CoV-2 or SARS-CoV-2-related disease in the cohort, with a reporting frequency of once every two years. The decision that continued follow-up is no longer meaningful and the study is discontinued is made by the sponsor.
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Studien slutar enrollera när deltagarna i kohorten inte längre erbjuds vaccination. Uppföljning planeras fortgå så länge det fortfarande uppkommer fall av SARS-CoV-2 eller SARS-CoV-2-relaterad sjukdom i kohorten, med en rapporteringsfrekvens av en gång vartannat år. Beslutet om att fortsatt uppföljning inte längre är meningsfull och studien avbrytes görs av sponsorn. |
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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 | 24 |
E.8.9.1 | In the Member State concerned days | |