A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
- Summary
- The study is designed as a Phase III, double-blind, multi-center, randomized, active-controlled study in which four groups of participants (n=554 per group) will receive either one of three different manufacturing lots of SII-YFV or STAMARIL® - a licensed and WHO pre-qualified YFV.
- Short title
- A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
- Official title
- A Phase III, Multicenter, Double Blind, Randomized Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2024-01-30
- First posted
- 2022-07-07
- Registry last updated
- 2023-11-28
- Primary completion date
- 2024-01-30
- Start date
- 2022-09-16
- Participants
- 2,216
- Participant count basis
- Estimated
- Planned participants
- 2,216
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05447377
- ClinicalTrials.gov ID
- NCT05447377
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
YF neutralizing antibody (NAb) seroconversion
Timeframe: Day 28 post-vaccination
Non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50). Percentage seroconversion\* on Day 28 post-vaccination \* Seroconversion is defined as a four-fold rise in YF NAb (PRNT50) titres from baseline
Yellow Fever Vaccine GMTs
Timeframe: Day 0 pre-vaccination and Day 28 post-vaccination
GMTs on Day 0 pre-vaccination and Day 28 post-vaccination Equivalence of the immune responses generated by three different manufacturing lots of SII-YFV
- Sex
- All
- Age groups
- Children
- Minimum age
- 9 Months
- Maximum age
- 12 Months
- Healthy volunteers
- Yes
- 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-age until the day before they reach 12-months/1-year-of-age)
- Parental/ guardian ability and willingness to provide informed consent (as per local requirements/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 and treatments in infants for the duration of the study
- 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 after the last recorded fever].
- Previous history of laboratory confirmed infection with yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.
5. Previous vaccination against yellow fever, measles, mumps, rubella, Neisseria meningitidis serogroup A, TBE, JE, or dengue fever.
6. Receipt of any vaccine within past 28 days or planned vaccination until completion of day 28 study visit 7. 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 8. Receipt of immunoglobulin therapy and/or blood products since birth or planned administration until completion of Day 28 visit 9. Current or planned participation in another interventional study at any point throughout the entire study period 10. Receipt of any other investigational product or unlicensed medication in the preceding 28 days, or planned use until completion of Day 28 visit 7. Presence of significant malnutrition (weight-for-height z-score < -3SD)
- Center for Vaccine DevelopmentBamako, MaliRecruiting
- MRC Unit The Gambia at LSHTMBanjul, The GambiaRecruiting
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Yellow fever Primary condition