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VLA1553-403 Pregnancy Surveillance Study
Sponsor: Valneva Austria GmbH
Summary
This post-marketing, observational study evaluates pregnancy and infant outcomes up to 12 weeks after delivery among women who received the chikungunya vaccine (VLA1553) during pregnancy or within 30 days before their last menstrual period. A matched comparator cohort of pregnant women vaccinated with routine, pregnancy-recommended vaccines (not exposed to VLA1553) is included. No study procedures beyond routine care are performed.
Official title: Observational Study to Evaluate the Safety of Live-attenuated Chikungunya Virus Vaccine (VLA1553) in Pregnant Women Exposed to the Vaccine in Brazil
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-03-31
Completion Date
2027-12-31
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
Live-attenuated CHIKV vaccine VLA1553
Non-interventional study: VLA1553 is used in the pilot vaccination strategy which will start along with this observational study.
Vaccine(s) approved for use during pregnancy by the MoH
Vaccine(s) approved for use during pregnancy by the MoH