Overview
The purpose of this pragmatic randomized trial is to evaluate the vaccine effectiveness of the COVID-19 vaccine, mRNA-1273, in adults aged 50-64 years without known risk factors for severe COVID-19 infection. Participants will be randomized 1:1 to either COVID-19 vaccine or no COVID-19 vaccine.
Description
The study is a pragmatic, registry-based, open-label, individually randomized trial. The Danish nationwide administrative health registries will be used for data collection including baseline information, follow-up data, and safety monitoring. The study aims to randomize a total of 285,000 participants. Participants will be individually randomized 1:1 to receive either a COVID-19 vaccine or no COVID-19 vaccine. The study is designed to assess the vaccine effectiveness of the COVID-19 vaccine vs. no COVID-19 vaccine on the risk of medically attended COVID-19 infection.
Eligibility
Inclusion Criteria:
- Age 50-64 years
- Informed consent form has been signed and dated
Exclusion Criteria:
- Medical conditions that increase the risk of severe COVID-19, which will be assessed through self-reporting. These medical conditions include:
- Asthma
- Cancer (excluding non-melanoma skin cancer)
- Cardiomyopathies
- Cerebrovascular disease
- Chronic kidney disease
- Chronic lung disease
- Cystic Fibrosis
- Dementia
- Diabetes
- Down syndrome
- Heart failure
- Human Immunodeficiency Virus
- Immunosuppressive therapy
- Ischemic heart disease
- Liver disease
- Neurological/neuromuscular disease
- Psychiatric disease (psychotic, schizophrenic, schizotypal, depressive, and bipolar (affective) disorders).
- Severe obesity (body mass index \>35 kg/m2)
- Severe substance abuse
- Short bowel syndrome
- Solid organ transplant or hematological transplant
- Apart from these, there are no specific exclusion criteria for this study