By InvitationNot Applicable

Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil

Brazil5,000 participantsStarted 2026-02-02

Plain-language summary

This is an observational study with primary data collection, which will combine a prospective safety cohort study and an SCRI study.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female participants who received a single dose of VLA1553 at a vaccination unit while participating in the pilot vaccination strategy.
✓. Individuals that are target for the pilot vaccination strategy at the time of vaccination.
✓. Individuals understanding and being able to comply with all scheduled follow-up calls/contacts and study procedures.
✓. Have given informed consent/assent prior to entering the study.

Exclusion criteria

✕. Individuals who have received investigational products within the 30 days prior to VLA1553 vaccination, or individuals who have received VLA1553/IXCHIQ previously or any authorized or approved CHIKV vaccine.
✕. Individuals residing outside of the study municipalities or are not expected to remain in the study municipalities for the next 24 weeks after vaccination.
✕. Pregnant women: women exposed to VLA1553 anytime during their pregnancy or within 30 days preceding their last menstrual period will be invited to participate in a separate pregnancy surveillance study (study identifier VLA1553-403).

What they're measuring

To estimate the incidence rates of a predefined set of AEs which constitute safety concerns according to the VLA1553 Risk Management Plan following the administration of the live-attenuated VLA1553 vaccine

Timeframe: From enrollment until Day 60

Trial details

NCT IDNCT07254702

SponsorValneva Austria GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10-31

View on ClinicalTrials.gov More Chikungunya Virus Infection trials