DENGUE VIRUS, SEROTYPE 2, LIVE, ATTENUATED, DENGUE VIRUS, SEROTYPE 2, EXPRESSING DENGUE VIRUS, SEROTYPE 1, SURFACE PROTEINS, LIVE, ATTENUATED, DENGUE VIRUS, SEROTYPE 2, EXPRESSING DENGUE VIRUS, SEROTYPE 3, SURFACE PROTEINS, LIVE, ATTENUATED, DENGUE VIRUS, SEROTYPE 2, EXPRESSING DENGUE VIRUS, SEROTYPE 4, SURFACE PROTEINS, LIVE, ATTENUATED for Dengue fever

Inclusion criteria

• {"criterion_text":"-Able to participate in all parts of the study"}
• {"criterion_text":"-Signed written informed consent"}
• {"criterion_text":"-18 years of age or older"}
• {"criterion_text":"-Negative pregnancy test (urine HCG) for women of childbearing potential"}
• {"criterion_text":"-Planning to travel to a dengue fever endemic country. The guidelines by the Swedish Society for Infectious Diseases Physicians will be used in a shared decision-making process when deciding on vaccination"}

Exclusion criteria

• {"criterion_text":"-Unable to provide signed written informed consent"}
• {"criterion_text":"-Cancer diagnosis with active treatment (excluding hormone treatment only)"}
• {"criterion_text":"-Allergy to a component of the Qdenga® vaccine"}
• {"criterion_text":"-Not suitable for participation in the study according to the view of the investigator"}
• {"criterion_text":"-Participation or recent participation (within 30 days from inclusion) in a clinical trial with an investigational medicinal product"}
• {"criterion_text":"-Previous participation in this trial"}
• {"criterion_text":"-Previous vaccination with a dengue fever vaccine"}
• {"criterion_text":"-Pregnancy or breastfeeding"}
• {"criterion_text":"-Immunocompromised condition due to illness or medication which prevents vaccination with a live vaccine according to the view of the investigator"}
• {"criterion_text":"-Systemic cortisone treatment (inhaled corticosteroids are allowed)"}
• {"criterion_text":"-Previous or present hepatitis B, hepatitis C and/or HIV"}
• {"criterion_text":"-Chronic liver failure (Child-Pugh Class B or higher)"}
• {"criterion_text":"-Chronic kidney disease (CKD stage 3 or higher)"}
• {"criterion_text":"-Autoinflammatory disease (i.e. inflammatory bowel disease, rheumatological disease or dermatological disease)"}

Primary endpoints

• {"endpoint_text":"-IgG antibody levels in serum against TBEV, YFV, ZIKV and JE at day 90 after two doses of Qdenga compared to before vaccination","definition_or_measurement_approach":"Measurement of IgG antibody levels in serum against TBEV, YFV, ZIKV and JE at day 90 after two doses of Qdenga compared to before vaccination."}

Sweden

Earliest CTIS Part Ii Submission Date

30-04-2025

Latest Decision Or Authorization Date

14-05-2025

Processing Time Days

14

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Region Vaesterbotten

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Co-sponsors

• Umea University