Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rokote Laboratories Finland Oy
With
Oy Medfiles Ltd
Estimates OY
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Has voluntarily signed the written informed consent
Male or female aged ≥18 to ≤75 years
Good general health based upon the results of the medical history, laboratory tests, physical examination, ENT clinical examination, and vital signs as assessed by the investigator
Prior vaccination with at least two doses of any COVID-19 vaccine with last dose obtained ≥180 days before the planned baseline (Day 0) visit
Has a personal smartphone, tablet or computer with internet access, and is considered willing and able to report the data in the ePRO and to comply with the reporting timelines
Willing and able to comply with the instructions to participants
Not of childbearing potential or willing and able to use a highly effective contraception method consistently and correctly during the entire trial
You may not be if
Pregnant, planning to become pregnant, or breastfeeding women
Received any investigational drug \< 180 days prior baseline
Antigen positivity or PCR confirmed SARS-CoV-2 infection less than 180 days apart from screening or during screening and/or baseline
Any SARS-CoV vaccination was administrated \< 180 days prior the planned baseline (Day 0) visit
Any other vaccination within 60 days prior the planned baseline (Day 0) visit
Administration of immunoglobulins or blood products within 90 days prior baseline
Use of steroid nasal sprays within 30 days prior to screening
Use of any oral or nasal decongestants within 7 days prior to screening
Severe chronic cardiovascular and endocrinological diseases (e.g., medicine or insulin treated diabetes), liver and renal insufficiency or serious psychiatric diseases
Any diagnosed disease or abnormality in the nasal or upper respiratory tract, such as acute/chronic rhinosinusitis; nasal polyposis; mucosal pathology or tumor of nasal cavity, pharynx or nasopharynx; significant obstructive nasal deformity; recurrent epistaxis; sleep apnea; anosmia
Severe obesity (BMI ≥ 35)
Cancer treated within 5 years
Known allergy/hypersensitivity to any ingredients of the COV2 vaccine
Previous anaphylactic reaction
Any clinically significant abnormal finding in the screening laboratory tests
Inability to sign ICF or to understand and comply with trial related instructions and requirements
Individuals who are employees of, or directly affiliated with, the sponsor, or site staff or their immediate family members.
