A Study of SII Yellow Fever Vaccine to Compare Safety and Immunogenicity With STAMARIL® In Healthy Infants

Launched by SERUM INSTITUTE OF INDIA PVT. LTD. · Jul 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new yellow fever vaccine called SII Yellow Fever Vaccine (SII-YFV) to see how safe it is and how well it works in comparison to an already approved vaccine, STAMARIL®. The trial is open to healthy infants between 9 and 12 months old. Researchers will enroll a total of 2,216 infants, divided into four groups, to receive either one of three different versions of the SII-YFV or STAMARIL®. The aim is to find out how these vaccines affect infants and whether they produce a good immune response to protect against yellow fever.

To participate in this study, infants must be healthy and not have any current infections or a history of certain diseases, such as yellow fever or measles. Parents or guardians need to be willing to give consent and ensure that their child does not use certain herbal medicines during the study. Participants will receive a vaccination and will be monitored to see how they respond. This trial is a great opportunity to help improve vaccines for yellow fever and ensure they are safe and effective for young children. If you think your child might be eligible and you’re interested in learning more, please reach out to the study team for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy infants as established by medical history and clinical examination
• • 2. 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)
• • 3. Parental/ guardian ability and willingness to provide informed consent (as per local requirements/procedures), and to adhere to the protocol requirements.
• • 4. Intend to remain residing in the study area throughout study participation
• • 5. Parents/guardians willing to avoid the use of traditional/herbal local medications and treatments in infants for the duration of the study
• Exclusion Criteria:
• • 1. Fever (\> 37.5°C) or any clinically significant acute infection at time of vaccination \[Temporary exclusion criteria - participants may be rescreened at least 48 hours after the last recorded fever\].
• • 2. 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)