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

N/AEnrolling By InvitationNCT07254702

Valneva Austria GmbH5,000 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Chikungunya Virus Infection

Interventions

Live-attenuated CHIKV vaccine VLA1553BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (4)

Universidade Federal Do Ceará

Fortaleza, Ceará, Brazil

Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras

Belo Horizonte, Minas Gerais, Brazil

Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus

Laranjeiras, Sergipe, Brazil

Fundação Faculdade Regional De Medicina De São José Do Rio Preto

São Pedro, São Paulo, Brazil

Outcomes

Primary Outcomes

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

For each safety concern, the risk windows after VLA1553 administration are defined as: 1. 30 days for Chikungunya-like adverse reactions; 2. 60 days for cardiac events, choosing a more conservative window than the 42 days suggested by the Brighton Collaboration recommendations on myocarditis; 3. 60 days for arthritis to account for late-onset or potentially immune-mediated cases

Time frame: From enrollment until Day 60

Secondary Outcomes

To measure the relative risk associated with VLA1553 administration for a predefined set of AEs which constitute safety concerns as per the VLA1553 Risk Management Plan for those AEs that have a defined risk window following vaccination.

Time frame: From enrollment until Day 120

To assess the frequency of occurrence of predefined AEs which are medically attended or meet the criteria of seriousness.

1. Frequency of occurrence of predefined chronic chikungunya-like adverse reactions; 2. frequency of predefined SAEs; 3. frequency of occurrence of arthralgia; 4. frequency of occurrence of prolonged arthralgia; 5. frequency of predefined CHIKV infection symptoms; 6. frequency of occurrence of predefined chronic CHIKV infection symptoms

Time frame: From enrollment until Month 6

Data from ClinicalTrials.gov

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