A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
NCT05421611
Phase
Phase 3
Recruitment status
Completed
Participants
1,824
Lead sponsor
Serum Institute of India Pvt. Ltd.
Start date
2023-05-11
Number of sites
- 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.
- Short title
- A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
- Official title
- A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-05-10
- First posted
- 2022-06-16
- Registry last updated
- 2025-05-07
- Primary completion date
- 2024-05-10
- Start date
- 2023-05-11
- Actual participants
- 1,824
- Participants
- 1,824
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05421611
- ClinicalTrials.gov ID
- NCT05421611
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
YF neutralizing antibody (NAb) seroconversion rates
Timeframe: 28 days post vaccination
NI comparison for primary objective of the study will be based on seroconversion rate at 28 days post vaccination i.e. percentage of participants achieving seroconversion. Seroconversion is defined as a fourfold increase in neutralizing antibody from baseline.
GMTs achieved with SII-YFV versus STAMARIL
Timeframe: 28 days post vaccination
To compare the YF NAb geometric mean titres (GMTs) generated following SII-YFV to those generated following STAMARIL®.
Sources for outcomes
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 1 Year
- Maximum age
- 99 Years
- Healthy volunteers
- Yes
- 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
- 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
Sources for eligibility
- Victoria Biomedical Research Institute (VIBRI) - Kisumu County Referral HospitalKisumu, Kenya
- Kenya Medical Research Institute/ Centre for Research Disease Research (CRDR)Nairobi, Kenya
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Yellow fever Primary condition