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VLA1553-403 Pregnancy Surveillance Study

NCT07414524 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Chikungunya Virus Infection

Interventions

BIOLOGICAL

Live-attenuated CHIKV vaccine VLA1553

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

BIOLOGICAL

Vaccine(s) approved for use during pregnancy by the MoH

Vaccine(s) approved for use during pregnancy by the MoH

Sponsors & Collaborators

  • Fundação Butantan

    collaborator UNKNOWN

  • Coalition for Epidemic Preparedness Innovations

    collaborator OTHER

  • Valneva Austria GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07414524 on ClinicalTrials.gov