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

NCT03725618 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1788

Last updated 2025-04-08

No results posted yet for this study

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

Conditions

  • Yellow Fever

Interventions

BIOLOGICAL

Yellow Fever 17DD Vaccine

live attenuated vaccine based on the 17DD strain

Sponsors & Collaborators

  • Infectious Disease Institute, Kampala, Uganda

    collaborator OTHER

  • MRC/UVRI and LSHTM Uganda Research Unit

    collaborator OTHER

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • Centers for Disease Control and Prevention

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-09-01
Completion
2021-09-01

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03725618 on ClinicalTrials.gov