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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-25

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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This prospective safety cohort study will be conducted in selected Brazilian municipalities participating in a pilot vaccination strategy. A total of 5,000 participants will be recruited. The primary objective is to estimate the incidence rates of a predefined set of AEs which constitute safety concerns. The secondary objectives are to measure the relative risk associated with VLA1553 administration for a predefined set of AEs which constitute safety concerns, and to assess the frequency of occurrence of any collected AE which are medically attended or meet the criteria of seriousness This study also aims to investigate VLA1553's safety in underrepresented populations by collecting all AEs, not just AEs which constitute safety concerns.

Conditions

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Chikungunya Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Live-attenuated CHIKV vaccine VLA1553

Non-interventional study: VLA1553 is used in the pilot vaccination strategy which will start along with this observational study.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Individuals residing outside of the study municipalities or are not expected to remain in the study municipalities for the next 24 weeks after vaccination.
3. 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Valneva Late-Stage Clinical Development

Role: CONTACT

Phone: +43 1 206 20 0

Email: [email protected]

Other Identifiers

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VLA1553-406

Identifier Type: -

Identifier Source: org_study_id