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

PHASE3CompletedINTERVENTIONAL
Enrollment

1,824

Participants

Timeline

Start Date

May 11, 2023

Primary Completion Date

May 10, 2024

Study Completion Date

May 10, 2024

Conditions
Yellow Fever
Interventions
BIOLOGICAL

STAMARIL

"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."

BIOLOGICAL

SII-YFV

"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."

Trial Locations (2)

7180-40100

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

47855-00100

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

All Listed Sponsors
lead

Serum Institute of India Pvt. Ltd.

INDUSTRY

NCT05421611 - A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL | Biotech Hunter | Biotech Hunter