> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sii-yellow-fever-vaccine-to-compare-safety-and-cdb4abc6-8e15-4759-8564-7fe2c456998d > Record changed: 2026-10-13 # A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants NCT05447377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) Participants 2,216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) Lead sponsor Serum Institute of India Pvt. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) Start date 2022-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Title and summary **Summary** The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Short title** A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Official title** A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Dates **Completion date** 2024-01-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **First posted** 2022-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Registry last updated** 2023-11-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Primary completion date** 2024-01-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Start date** 2022-09-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Size and sites **Participants** 2,216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Planned participants** 2,216 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Lead sponsor** Serum Institute of India Pvt. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Identifiers **Registry ID** NCT05447377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **ClinicalTrials.gov ID** NCT05447377 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Outcomes ### Primary outcomes 1. YF neutralizing antibody (NAb) seroconversion Timeframe: Day 28 post-vaccination Non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50). Percentage seroconversion\\\* on Day 28 post-vaccination \\\* Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline ### Secondary outcomes 1. Yellow Fever Vaccine GMTs Timeframe: Day 0 pre-vaccination and Day 28 post-vaccination GMTs on Day 0 pre-vaccination and Day 28 post-vaccination Equivalence of the immune responses generated by three different manufacturing lots of SII-YFV Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 9 Months **Maximum age** 12 Months **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy infants as established by medical history and clinical examination 2. Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-age until the day before they reach 12-months/1-year-of-age) 3. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements. 4. Intend to remain residing in the study area throughout study participation 5. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study ### Exclusion criteria 1. Fever (> 37.5°C) or any clinically significant acute infection at time of vaccination \[Temporary exclusion criteria - participants may be rescreened at least 48 hours after the last recorded fever\]. 2. Previous history of laboratory confirmed infection with yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc. 5\. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever. 6\. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit 7\. 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 8\. Receipt of immunoglobulin therapy and/or blood products since birth or planned administration until completion of Day 28 visit 9\. Current or planned participation in another interventional study at any point throughout the entire study period 10\. Receipt of any other investigational product or unlicensed medication in the preceding 28 days, or planned use until completion of Day 28 visit 7\. Presence of significant malnutrition (weight-for-height z-score < -3SD) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Sites - Center for Vaccine DevelopmentBamako, MaliRecruiting - MRC Unit The Gambia at LSHTMBanjul, The GambiaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05447377) ## Related records ### Drugs (1) - [Yellow fever vaccine](https://trialight.com/data/asset/yellow-fever-vaccine-a73bff44-b504-4edb-ac31-7ffb2a0d4e1f.md) ### Lead sponsors (1) - [Serum Institute of India Pvt. Ltd.](https://trialight.com/data/company/serum-institute-of-india-pvt-ltd-83f1638e-64f7-4ee9-9ca0-7ae346be8b28.md) ### Conditions (1) - [Yellow fever](https://trialight.com/data/condition/yellow-fever-09f886cb-25a4-5e7c-8d66-55c40cf8cca5.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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