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Enrolling By Invitation NCT07414524

VLA1553-403 Pregnancy Surveillance Study

Conditions: Chikungunya Virus Infection

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 200
Sponsor: Valneva Austria GmbH

Location: Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras Belo Horizonte Minas Gerais

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.

Eligibility Criteria

Inclusion Criteria: VLA1553 vaccinated population: * Women who have received the single dose of the VLA1553 vaccine during pregnancy or within the 30 days prior to the first day of the last menstrual period. * Pregnant at the time of enrolment in the study. * The participant understands and agrees to comply with the study procedures. Control group: * Pregnant at the time of enrolment in the study. * Women who have received vaccine(s) approved for use during pregnancy by the MoH and who meet the matching criteria described in the protocol. * The participant understands and agrees to comply with the study procedures. * Women who have not received the VLA1553 vaccine during pregnancy or within the 30 days prior to the first day of the last menstrual period. Exclusion Criteria: * Women who do not provide informed consent. * Women who are not part of the target population of the pilot vaccination strategy at the time of vaccination.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07414524). StuddyBuddy aggregates publicly available trial information.