A clinical trial to assess Safety and Immunogenicity of SII yellow fever vaccine in Adults
- Registration Number
- CTRI/2024/03/063471
- Lead Sponsor
- Dr Prasad Kulkarni MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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 e 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method safety, solicited and unsolicited eventsTimepoint: solicited till day 10 post vaccination and unsolicited day 28 post vaccination and SAE till day 180 post vaccination