Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT04033068
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent obtained before any trial-related activities
2. Healthy men or women aged 18 to 55 years on the day of consenting
3. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study
4. All female participants must have a negative urine pregnancy serum pregnancy test at screening
5. Willingness not to become pregnant or to father a child during the entire study period by practising reliable methods of contraception as specified in protocol section 8.11.4
6. Availability during the duration of the trial
7. Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant
8. Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)
Exclusion Criteria:
1. Participation in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period (day 56)
2. History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
3. Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
4. History of drug addiction including alcohol dependence within the last 2 years
5. Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)
6. Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until the end of the treatment period (day 56)
7. Prior receipt of any Zika or Chikungunya vaccine
8. History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit
9. Recent infection within 1 week prior to Screening Visit (possibility of deferral)
10. Blood donations including plasma donations, 90 days prior to Screening Visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until the end of the treatment period (day 56)
11. Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
12. History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any haematological malignancy
13. Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
14. History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
15. History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
16. Abnormal laboratory values which, at the discretion of the investigator should lead to the exclusion of the subject
17. Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants. (Prior to taking any medication within 72 h before study vaccination, the subject should consult the investigator)
18. Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to first IMP administration, or anticipated use until completion of the end of treatment visit Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period (day 56)
19. Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
20. Unreliable contraception methods (for details please refer to protocol section 8.11.4)
21. Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04033068
Study Brief:
Protocol Section:
NCT04033068