Last updated: November 22, 2023
Sponsor: Serum Institute of India Pvt. Ltd.
Overall Status: Active - Recruiting
Phase
3
Condition
Fever
Treatment
SII Yellow Fever Vaccine
STAMARIL®
Clinical Study ID
NCT05447377
YWF:02
Ages 9-12 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy infants as established by medical history and clinical examination
- Male or female infants aged 9 to < 12 months (from the day they reach 9 months-of-ageuntil the day before they reach 12-months/1-year-of-age)
- Parental/ guardian ability and willingness to provide informed consent (as per localrequirements/procedures), and to adhere to the protocol requirements.
- Intend to remain residing in the study area throughout study participation
- Parents/guardians willing to avoid the use of traditional/herbal local medications andtreatments in infants for the duration of the study
Exclusion
Exclusion Criteria:
- 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 afterthe last recorded fever].
- Previous history of laboratory confirmed infection with yellow fever, measles, mumps,rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., denguefever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
- Previous vaccination against yellow fever, measles, mumps, rubella, Neisseriameningitidis serogroup A, TBE, JE, or dengue fever.
- Receipt of any vaccine within past 28 days or planned vaccination until completion ofday 28 study visit 7. A known hypersensitivity to any of the vaccine components (includinggelatin, eggs, egg products, or chicken protein) or history of a life threatening reactionto any past vaccine 8. Receipt of immunoglobulin therapy and/or blood products since birthor planned administration until completion of Day 28 visit 9. Current or plannedparticipation in another interventional study at any point throughout the entire studyperiod 10. Receipt of any other investigational product or unlicensed medication in thepreceding 28 days, or planned use until completion of Day 28 visit 7. Presence ofsignificant malnutrition (weight-for-height z-score < -3SD)
Study Design
Total Participants: 2216
Treatment Group(s): 2
Primary Treatment: SII Yellow Fever Vaccine
Phase: 3
Study Start date:
September 16, 2022
Estimated Completion Date:
January 30, 2024
Study Description
Connect with a study center
MRC Unit The Gambia at LSHTM
Banjul, 273
GambiaActive - Recruiting
Center for Vaccine Development
Bamako, 251
MaliActive - Recruiting
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