Status:
COMPLETED
Non- Inferiority Fractional-doses Trial for Yellow Fever Vaccine
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
KEMRI-Wellcome Trust Collaborative Research Program
Institut Pasteur
Conditions:
Yellow Fever
Eligibility:
All Genders
9-59 years
Phase:
PHASE4
Brief Summary
In the recent past there has been a number of large urban Yellow Fever outbreaks in sub-Saharan Africa, tropical South Americas, The demand for Yellow Fever vaccines in response to the large urban out...
Detailed Description
Yellow fever (YF) is a disease caused by a mosquito-borne flavivirus that is endemic in sub-Saharan Africa and tropical South America. Ninety percent of YF cases are in Africa where YF virus is transm...
Eligibility Criteria
Inclusion
- Individuals aged ≥18 - \<60 years of age.
- Children aged between 9 months and 12 months.
- HIV negative on serological screening OR HIV positive adults and children aged \> 18 months on serological testing, and no symptoms suggestive of current clinical immunosuppression and cluster of differentiation-4 (CD4) count\>200 (for adults) and CD4% \> 25% (for children aged 9-12 months) within the last 6 months.
- Ability to provide informed consent to participate in the study
Exclusion
- Known contraindications to YF vaccination such as allergies to egg protein and chicken products or any component of the vaccine (including gelatin, eggs, eggs products or chicken products), immunodeficiency, known thymus disorder, such as thymoma and myasthenia gravis
- Using corticosteroids or other immunosuppressive therapy
- Thymus disorder, such as thymoma and myasthenia gravis
- Acute febrile disease on the day of vaccination with temperature \>37.5 degrees Celsius is a temporal contraindication.
- Previous YF vaccination
- Previous YF infection as determined from history
- Pregnancy (as determined by a urine test on the proposed day of vaccination) and lactating women
- Planning to migrate out of the study areas before the end of the study follow-up
- Planning to travel to a country requiring YF vaccination certificate within the first year after vaccination.
- Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the volunteer or interfere with the outcome of the study.
Key Trial Info
Start Date :
November 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2023
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04059471
Start Date
November 11 2019
End Date
June 24 2023
Last Update
February 9 2024
Active Locations (2)
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1
KEMRI-Wellcome Trust Research Programme
Kilifi, Coast, Kenya, 254
2
Epicentre, Mbarara.
Mbarara, Uganda