COVID-19: A Trial Studying the SARS-CoV-2 mRNA Vaccine CVnCoV to Learn About the Immune Response, the Safety, and the Degree of Typical Vaccination Reactions When CVnCoV is Given at the Same Time as a Flu Vaccine Compared to When the Vaccines Are Separately Given in Adults 60 Years of Age and Older (CV-NCOV-011)

This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19, mRNA Vaccine, SARS-CoV-2 mRNA Vaccine (CVnCoV), Quadrivalent influenza vaccine (QIV) Read More

Inclusion Criteria:

• Male and female participant of 60 years of age or older, at the time of signing the informed consent.
• Participants who are generally healthy. Note: healthy participant is defined as an individual who is in good general health, not having any symptomatic mental or physical disorder requiring regular or frequent medication. Subjects can be enrolled if the regular or frequent medication keeps the condition well controlled and asymptomatic with the treatment according to the investigator's discretion.
• Body mass index (BMI) within the range 18.0 and ≤35.0 kg m2 (inclusive).
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion Criteria:

• Female participant of child-bearing potential.
• Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 28 days or 5 times ½ life of the investigational product preceding the administration of the study vaccine, or planned use during the study period.
• Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or planned receipt of any vaccine within 28 days of study vaccine administration.
• Receipt of any investigational, authorized or licensed, SARS-CoV-2 or other coronavirus vaccine prior to the administration of the CVnCoV study vaccine or planned receipt during the study.
• Receipt of an influenza vaccine within 6 months prior to enrollment in this study or planned receipt during the study.
• Receipt of any investigational or licensed lipid nanoparticles (LNP)-formulated mRNA vaccine prior to the administration of the study vaccine.
• Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals and methotrexate) for >14 days total within 6 months preceding the administration of study vaccine or planned use during the study. For corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14 consecutive days or more. The use of inhaled, topical, intra-articular, intra-bursal corticosteroids is permitted.
• Administration of immunoglobulins (Igs) and/or any blood products within the 3 months preceding the administration of the study vaccine.
• Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, or hepatitis C virus infection.
• Active cancer (under current treatment) or cancer requiring planned treatment in the past 5 years excluding non-melanoma skin cancer or cancers with excellent clinical prognosis (e.g. carcinoma in situ of the uterine cervix).
• History of known immune-deficiency disorders disease.
• History of angioedema (known C1 inhibitor deficiency).
• History of any anaphylactic reactions.
• Contraindications to administration of QIV as per current label, including history of severe allergic reactions (e.g., anaphylaxis) to any component of the QIV vaccine, including egg protein.
• Any known allergy to any component of CVnCoV or aminoglycoside antibiotics.
• History of confirmed SARS, MERS or COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within 2 weeks prior to enrollment.
• Received or plan to receive 2021 inactivated seasonal influenza vaccine prior to or during the study and for the remaining of the 2021/2022 influenza season.
• Participants with a significant acute or chronic medical or psychiatric illness that, in the opinion of the investigator, precludes study participation (e.g., study participation may lay risks on the subject, renders the subject unable to meet the protocol requirements of the study, or may interfere with the reliability of the participant´s study readouts/results). These conditions may include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological or psychiatric illnesses. However, those with well-controlled and those who are well-controlled and stable on their regular medication for their medical condition and have been so for the 12 weeks preceding the enrollment in this study can be included in the study.
• Participants with impaired coagulation or any bleeding disorder in whom an intramuscular injection or a blood draw is contraindicated.