Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Ful… (NCT03725618) | Clinical Trial Compass
CompletedPhase 4
Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old
United States1,788 participantsStarted 2018-11-01
Plain-language summary
A randomized clinical trial comparing fractional dose Yellow Fever vaccination to the full dose among children aged 9-23 months in Uganda. Children will have immune response assessed at baseline, 4 weeks, and 12 months after vaccination.
Enrolled participants will be randomized to one of three arms:
A. One-fifth fractional dose (0.1 ml) administered subcutaneously B. One-half fractional dose (0.25 ml) administered subcutaneously C. Full dose (0.5 ml) administered subcutaneously
Who can participate
Age range9 Months – 23 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 9 to 23 months at the time of enrollment
✓. Intent to stay in the health center catchment area and availability to do study visits at 2 weeks, 4 weeks, and 12 months after enrollment date
✓. Informed consent signed by parent/guardian for child's participation in the study, including blood sample collections at 4 week and 12 month visits post-vaccination
✓. Willingness of parent/guardian to be contacted by study personnel by telephone and through home visits if they cannot be reached by telephone.
Exclusion criteria
✕. Verbal or written report of previous vaccination against YF
✕. Verbal or documented history of YF disease
✕. Contraindication for YF vaccine including:
✕. Allergy to eggs, gelatin, or neomycin
✕. Severe immune deficiency immunological including symptomatic HIV infection and HIV- infected persons with CD4 T-cell counts ≤200 cells/ mm³, primary immunodeficiencies, having received immunosuppressive doses of oral or injectable corticosteroids (or equivalent), having received immunomodulatory or chemotherapeutic agents
✕. Thymus disorder
✕. History of malignant neoplasm or recent hematopoietic stem cell transplantation
✕
What they're measuring
1
Immune response at 4 weeks in terms of seroconversion following vaccination