A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL (NCT05421611) | Clinical Trial Compass
CompletedPhase 3
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
Kenya1,824 participantsStarted 2023-05-11
Plain-language summary
The study is designed as a Phase III, double-blind, multicenter, randomized, active-controlled, parallel-group design in which two groups of participants will receive either SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. The study will start only after the approval from the applicable ethics committees and national regulatory agencies.
Who can participate
Age range1 Year – 99 Years
SexALL
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Inclusion criteria
✓. Male or female volunteers aged ≥ 1 year
✓. Healthy volunteers as determined by medical history and clinical examination
✓. Participants willing to adhere to the protocol requirements and to provide informed consent for participants ≥ 18 years of age. For participants \< 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants at least 7 years of age in Kenya)
✓. Intend to remain residing in study area throughout the study participation
✓. Female participants of childbearing potential\* must have practiced adequate contraception\*\* and agree to continue adequate contraception till Day 28 post-vaccination.
✓. Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.
✓. Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study
Exclusion criteria
✕. Fever (\> 37.5°C) or any clinically significant acute infection at time of vaccination \[Temporary exclusion criteria - participants may be re-screened at least 48 hours after the last recorded fever\]
✕. Use of systemic (oral or parenteral) antibiotics or antiviral agents within the past 7 days. \[Temporary exclusion criteria - participants may be re-screened at least 7 days after last dose of antibiotics or antiviral agents\]
✕. Use of traditional/herbal local medications and treatments in the past 7 days \[Temporary exclusion criteria - participants may be re-screened at least 7 days after last consumption of traditional/herbal local medications and treatment\]
✕. Previous history of laboratory confirmed infection with yellow fever and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
✕. Previous vaccination against yellow fever, TBE, JE, or dengue fever.
✕. Receipt of any vaccine within past 28 days or planned vaccination until completion of Day 28 visit
✕. Known or suspected impairment of immunological function based on medical history and physical examination.
✕. Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol