Status:
COMPLETED
A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
Lead Sponsor:
Serum Institute of India Pvt. Ltd.
Conditions:
Yellow Fever
Eligibility:
All Genders
1-99 years
Phase:
PHASE3
Brief 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 l...
Detailed Description
There will be three scheduled visits during the study. A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination. Throughout the study, pa...
Eligibility Criteria
Inclusion
- 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
- 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
- History of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (\> 0.5 mg/kg/day of prednisolone or equivalent) or other immune modifying drugs including the use of glucocorticoids. The use of topical/inhaled/per nasal glucocorticoids will be permitted.
- A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.
- Receipt of any immunoglobulin therapy and / or blood products in the past 60 days or planned administration until completion of Day 28 visit.
- Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period
- Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit
- Uncontrolled coagulopathy or blood disorder contraindicating subcutaneous injections or blood sampling
- Be an employee of, or direct descendant (child or grandchild) of any person employed by the investigator or sponsor.
- Pregnant or lactating women
- Requirement of Yellow Fever vaccination certificate for travelling purpose
- History of thymus dysfunction including myasthenia gravis, thymoma, thymectomy
- History or presence of significant alcoholism or drug abuse in the past one year
- Major congenital or genetic defect
- Any other condition which in the opinion of the investigator will jeopardize the safety of the participant or compromise the assessment of the study objectives
Key Trial Info
Start Date :
May 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2024
Estimated Enrollment :
1824 Patients enrolled
Trial Details
Trial ID
NCT05421611
Start Date
May 11 2023
End Date
May 10 2024
Last Update
May 7 2025
Active Locations (2)
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1
Victoria Biomedical Research Institute (VIBRI) - Kisumu County Referral Hospital
Kisumu, Kenya, 7180-40100
2
Kenya Medical Research Institute/ Centre for Research Disease Research (CRDR)
Nairobi, Kenya, 47855-00100