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VLA1553-403 Pregnancy Surveillance Study

StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Not Yet Recruiting → Enrolling by Invitation
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Mar 31, 2026 to Jun 11, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07414524
Lead Sponsor Valneva Austria GmbH
Collaborators: Butantan Foundation, Coalition for Epidemic Preparedness Innovations
Conditions
(from sponsor)		 Chikungunya Virus Infection
Related terms Chikungunya Fever
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov