A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL

NCT05421611 | Completed Phase 3 DMC

• 1 other identifier: YWF:03
• Study Type: interventional
• Target: 1,824
• Locations: 1 country
• Sites: 2

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 licensed and WHO pre-qualified YFV. The study will start only after the approval from the applicable ethics committees and national regulatory agencies.

Conditions

Yellow Fever

Outcome Measures

Primary Outcomes (1)

• YF neutralizing antibody (NAb) seroconversion rates

  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.

  28 days post vaccination

Secondary Outcomes (1)

• GMTs achieved with SII-YFV versus STAMARIL

  28 days post vaccination

Study Arms (2)

SII-YFV

EXPERIMENTAL

Live attenuated Yellow Fever Virus (17D-213 Strain) not less than 1000 IU/dose propagated in specific pathogen-free chick embryos Diluent: 0.5 mL of sterile water for injection

Biological: SII-YFV

STAMARIL

ACTIVE COMPARATOR

Live attenuated Yellow Fever Virus (17D-204 Strain) not less than 1000 IU/dose produced in specified pathogen-free chick embryos Solvent: Sodium Chloride 2.0 mg; Water for injections up to 0.5 mL

Biological: STAMARIL

Interventions

STAMARIL BIOLOGICAL

STAMARIL® contains the 17D-204 vaccine strain, which is used in many currently produced yellow fever vaccines. STAMARIL is specific pathogen free embryonated hen's egg based and is prepared by harvesting and stabilizing the virus collected from the homogenized chicken embryos infected with YF vaccine virus. STAMARIL® will be used as a comparator in the study. It is a live, attenuated, freeze-dried (lyophilized) vaccine and is to be reconstituted with solvent.

STAMARIL

SII-YFV BIOLOGICAL

SII-YFV contains the 17D-213 vaccine strain, a derivative of 17D-204 strain which is used in many currently produced yellow fever vaccines. SIIPL imported the YF WHO Primary Seed Virus lot 213-77 from National Institute for Biological Standards and Control (NIBSC) for preparation of the master seed virus, working seed virus and the vaccine. The SII-YFV is specific pathogen free embryonated hen's egg based and is prepared by harvesting and stabilizing the virus collected from the homogenized chicken embryos infected with YF working seed virus. SII-YFV will be provided in vial presentation for the study. It is a live, attenuated, freeze-dried (lyophilized) vaccine and is to be reconstituted with sterile water for injection.

SII-YFV

Eligibility Criteria

• Age: 1 Year - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead

Study Sites (2)

Victoria Biomedical Research Institute (VIBRI) - Kisumu County Referral Hospital

Kisumu, 7180-40100, Kenya

Location

Kenya Medical Research Institute/ Centre for Research Disease Research (CRDR)

Nairobi, 47855-00100, Kenya

Location

MeSH Terms

Conditions

Yellow Fever

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: May 11, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within 6 months of publication of the study data
• Access Criteria: Local regulatory authorities, ethics committee

Locations

KE (2)