Prospective Safety Cohort Study After VLA1553 Vaccination in Municipalities Selected for Participation in the VLA1553 Pilot Vaccination Strategy in Brazil
Live-attenuated CHIKV vaccine VLA1553: Non-interventional study: VLA1553 is used in the pilot vaccination strategy which will start along with this observational study.
Study summary
This is an observational study with primary data collection, which will combine a prospective safety cohort study and an SCRI study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 who are not expected to remain available for the study follow-up 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).
Primary outcome measure(s)
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 — From enrollment until Day 60 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
Trial sites (3)
Facility
City
Region
Status
Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras
Belo Horizonte
Minas Gerais
Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus
Laranjeiras
Sergipe
Fundação Faculdade Regional De Medicina De São José Do Rio Preto
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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