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Immunogenicity of Yellow Fever Vaccine in a Pediatric Population Vaccinated at 12-23 Months of Age in Argentina

NCT05644145 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 361

Last updated 2024-12-09

No results posted yet for this study

Summary

Northern Argentina is a risk area for yellow fever (YF). Recent studies have suggested that immunity wanes in children vaccinated between 9 and 23 months of age. In 2015, a collaborative study conducted by the Ministry of Health (MoH) of Argentina, the Pan American Health Organization (PAHO), and the US Centers for Disease Control and Prevention (CDC) assessed the immunogenicity and safety of co-administration of YF and MMR vaccines in a pediatric population at 12-13 months of age. A total of 741 children presenting for routine immunization at 12-13 months of age enrolled and completed the study. It is now four to seven years since this pediatric group received their YF vaccinations. This cohort is unique because their initial YF vaccination and immune response to the vaccine dose are well characterized. Contact information collected during the earlier study will be used to locate the children. If consent is obtained, a 5ml specimen of blood will be collected and shipped to the CDC's Arboviral Diseases Reference Laboratory (ADRL) in Fort Collins, CO for plaque reduction neutralization testing using a 50% cut-off (PRNT50) to detect YF virus-specific neutralizing antibodies. Children with neutralizing antibody titers that are higher than their baseline titer collected approximately 28 days following YF vaccination will have PRNTs done for cross-reacting flaviviruses.

Conditions

  • Yellow Fever

Interventions

BIOLOGICAL

Serological study after yellow fever vaccination

It is a serological survey of the cohort of children who participated in the preliminary investigation and seroconverted after vaccination against yellow fever.

Sponsors & Collaborators

Principal Investigators

  • Carla Vizzotti · Ministry of Public Health, Argentina

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-06
Primary Completion
2023-09-07
Completion
2025-07-30

Countries

  • Argentina

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 NCT05644145 on ClinicalTrials.gov