A clinical trial to assess Safety and Immunogenicity of SII yellow fever vaccine in Adults

A Phase 2/3 Multicenter, Double blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity with STAMARIL in Adults - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063471

Enrollment

656

Registered

2024-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SII yellow fever vaccine: dose- 0.5ml, frequency- single dose route of administration- subcutaneous total duration of intervention - 1 day Control Intervention1: STAMARIL: dose- 0.5

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female volunteers aged >= 18 years 2. Healthy volunteers as determined by medical history and clinical examination 3. Participants willing to adhere to the protocol requirements and to provide informed consent. 4. Intend to remain residing in study area throughout study participation 5. Female participants of childbearing potential having a negative pregnancy test within 24 hours prior to IP administration and agreeing to practice

Exclusion criteria

Exclusion criteria: 1. Fever Axillary Temperature more than 37.5 C or any clinically significant acute infection at time of vaccination Temporary exclusion criteria participants may be reassessed for eligibility at least 48 hours after the last recorded fever 2. Previous history of infection with yellow fever, and other flaviviruses dengue fever, tick-borne-encephalitis, Japanese encephalitis, West Nile virus, zika virus, etc. 3. Previous vaccination against yellow fever, TBE, JE, or dengue fever. 4. 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. 5. Receipt of any immunoglobulin therapy and or blood products in the past 60 days or planned administration until completion of Day 28 visit. 6. Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period. 7. Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit 8. Pregnant or lactating women 9. Requirement of Yellow Fever vaccination certificate for travelling purpose 10. Major congenital or genetic defect

Design outcomes

Primary

Measure	Time frame
To demonstrate the non-inferiority between the SII-Yellow Fever vaccine and Stamaril with respect to seroconversion rates (four fold rise to baseline PRNT50 titres) post-vaccinationTimepoint: PRNT50 titres will be measured at baseline pre-vaccination and post-vaccination at Day 28	—

Secondary

Measure	Time frame
safety, solicited and unsolicited eventsTimepoint: solicited till day 10 post vaccination and unsolicited day 28 post vaccination and SAE till day 180 post vaccination	—

Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Pvt Ltd

drpsk@seruminstitute.com02071946836

Outcome results