Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT07163845

Assessment of Chikungunya Virus Seroprevalence Before VLA1553 Vaccination in the Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
5,354 (actual)
Sponsor
Valneva Austria GmbH · Industry
Sex
All
Age
2 Years
Healthy volunteers
Accepted

Summary

This is a cross-sectional serosurvey using household cluster sampling conducted before the VLA1553 pilot vaccination strategy will be implemented in about 10 municipalities in Brazil.

Detailed description

Households will be selected randomly using a multi-stage random sampling at the census tract, street, and household levels, to select study participants. The study aims to prospectively evaluate the association between vaccination uptake and previous CHIKV exposure (pre-existing immunity to CHIKV infection) in the age-group approved per label in Brazil (e.g., adults \[≥18 years of age\] or individuals ≥12 years of age). Seroprevalence among vaccinated and unvaccinated individuals will be used to parameterize a probabilistic bias analysis conducted as part of the VE study. Finally, the study will explore the prevalence of CHIKV exposure in the different study communities before the VLA1553 pilot vaccination strategy in individuals ≥2 years of age.

Conditions

Interventions

TypeNameDescription
BIOLOGICALLive-attenuated CHIKV vaccine VLA1553Non-interventional study: VLA1553 is used in the pilot vaccination strategy which is carried out after this observational study.

Timeline

Start date
2025-09-22
Primary completion
2026-07-31
Completion
2026-12-31
First posted
2025-09-09
Last updated
2026-02-11

Locations

4 sites across 1 country: Brazil

Source: ClinicalTrials.gov record NCT07163845. Inclusion in this directory is not an endorsement.