Yellow Fever
Conditions
Interventions
SII YFV
Sponsors
Serum Institute of India Pvt Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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. Use of systemic (oral or parenteral) antibiotics or antiviral agents within the past 7 days. [Temporary exclusion criteria – participants may be rescreened at least 7 days after last dose of antibiotics or antiviral agents] 3. Use of traditional/herbal local medications and treatments in the past 7 days by the prospective participant [Temporary exclusion criteria – participants may be re-screened at least 7 days after last consumption of traditional/herbal local medications and treatment] 4. 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. Presence of significant malnutrition (weight-for-height z-score 0.5mg/kg/day of prednisolone or equivalent) or other immune modifying drugs including the use of glucocorticoids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage seroconversion | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants showing seroprotection (YF NAb > 1:10);Seropositivity of individual participant for the diseases - measles, mumps and rubella;Seroprotection defined as post-vaccination serum bactericidal assay (rSBA) titer = 8;Immediate adverse events ;Solicited local adverse events (Tenderness, Redness, Swelling, and Induration) Solicited systemic adverse events (Fever, Vomiting, Rash, Loss of appetite, Drowsiness, Irritability, and Crying) | — |
Countries
Gambia, Mali
Contacts
Public ContactSajjad Desai
Deputy Medical Director
Outcome results
None listed