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Booster Vaccine for Yellow Fever

NCT05332197 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2022-04-18

No results posted yet for this study

Summary

This is a phase III trial on Children. The investigators will enroll a total of 750 participants in Fajikunda Health Center (Gambia) The aims of the study are

* To describe the safety and immunogenicity of a booster dose of a licensed yellow fever vaccine administered to 3 different age cohorts of children, following a documented primary dose of a yellow fever vaccine administered at nine-months of age.
* To characterise the rate of yellow-fever PRNT sero-reversion (seropositive to seronegative) over a period of 9 months to 8 years following a single primary dose of yellow fever vaccine administered to Gambian infants at nine months age.
* To profile the immune response to the booster dose of YF vaccine in order to explore underlying mechanisms for longevity of vaccine-induced antibody.

Conditions

  • Yellow Fever

Interventions

BIOLOGICAL

17D Yellow fever vaccine

This vaccine contains the Rockefeller17D-substrain 204 strain of Yellow fever virus. The exact potency of each batch is released with the certificate of analysis that accompanies each batch and the potency confirmed at time of release closest to internal minimum specification. This vaccine is the same vaccine used by the national EPI program

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2023-06-30
Completion
2023-09-30

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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 NCT05332197 on ClinicalTrials.gov