Immunogenicity of Fractional One-fifth and One-half Doses of Yellow Fever Vaccine Compared to Full Dose in Children 9-23 Months Old

Completed · Phase 4

Conditions studied: Yellow Fever

In brief

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

Key facts

Study ID

NCT03725618

Run by

Centers for Disease Control and Prevention

People needed

1788

Starts

2018-11-01

Expected to finish

2021-09-01

Last updated by the study team

2025-04-08

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Serious illness/fever (mild illness without fever is not an exclusion criterion)
• Administration of immunoglobulins or other blood derivative within 6 months of enrollment in the study or during the study
• a. Exception: children with a history of Kawasaki disease who received gammaglobulin cannot be enrolled if they received it in the previous 11 months.
• Administration of any other attenuated viral vaccine in the month prior to enrollment, or if the administration of any other attenuated viral vaccine is expected during the month after enrollment. Note: the administration of measles vaccine on the same day as YF vaccination is not a contraindication; however, if Uganda introduces measles-rubella vaccine (MR), participants will not be able to receive MR on the same day as YF vaccine due to possible interference between rubella and YF vaccine. In this situation, children will have to delay study enrollment until 1 month after MR vaccination.
• Participating in another clinical drug trial of a drug, vaccine, or medical device
• Severely underweight defined as ≤ 3rd percentile in the height/weight tables
• Severe reaction to prior vaccination
• Any chronic or other condition that, in the opinion of the study staff, represents a health risk to the participant or interferes with the evaluation of the response to the vaccine

Where it is running

• Centers for Disease Control and Prevention — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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