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Yellow Fever Vaccine Immunity After 1 Dose of Vaccine in Children and Adults: a Cohort Study in Non-endemic Area
The study main objective is to assess the immune status of children and adults who have never vaccinated, they will receive the first dose of 17DD yellow fever vaccine provided by the study and will be monitored for 10 years. Depending on the results of the analyzed of the data, the period of monitoring may be extended.
This is a Phase IV study cohort, uncontrolled, composed of two segments: children and healthy adults. It will be included 2756 children and 2005 adults, evaluated initially in six different times (before vaccination, 30-45 days, 1 year, 4 years, 7 years and 10 years after vaccination). The Paraiba state was selected for the study because in this region there are no yellow fever virus dissemination and therefore no NIP recommendation for people's routine vaccination. However, the NIP indicate yellow fever vaccination for individuals who are moving to areas with virus circulation. The study will take place in six (6) Basic Health Units of three (3) municipalities (2 units per municipality) in the state of Paraíba. The selected municipalities are: Alhandra, Caaporã and Conde. The study target population consisted of healthy children and adults of both sexes. Children must be between 9 months and 4 years,11months and 29 days; adults between 18 and 50 years. It will be eligible for the study, people who have never received the yellow fever vaccine checked in vaccine design and history and who agree to participate. Not be included participants with any contraindication to vaccination against yellow fever and individuals who previously moved to risk areas for extended periods.
Age
0 - 50 years
Sex
ALL
Healthy Volunteers
Yes
Unidade de Saúde da Família Oiteiro I
Alhandra, Paraíba, Brazil
Unidade Saúde da Família Mata Redonda 1
Alhandra, Paraíba, Brazil
Unidade de Saúde da Família Cupissura I
Caaporã, Paraíba, Brazil
Unidade de Saúde da Família Santo Antônio
Caaporã, Paraíba, Brazil
Unidade de Saúde da Família N Sra da Conceição
Conde, Paraíba, Brazil
Unidade de Saúde da Família N Sra das Neves
Conde, Paraíba, Brazil
Start Date
July 1, 2016
Primary Completion Date
June 1, 2026
Completion Date
December 1, 2027
Last Updated
June 13, 2023
4,761
ACTUAL participants
yellow fever vaccine
BIOLOGICAL
Lead Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
NCT04638647
NCT04119713
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06694766