VLA1553-403 Pregnancy Surveillance Study
ConditionChikungunya Virus Infection
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorValneva Austria GmbH
About this trial
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
Qualifiers
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.
Pregnant at the time of enrolment in the study.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Live-attenuated CHIKV vaccine VLA1553
- Vaccine(s) approved for use during pregnancy by the MoH
Treatment groups
200 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Valneva Austria GmbH
Lead sponsor
Butantan Foundation
Collaborator
Coalition for Epidemic Preparedness Innovations
Collaborator
Source ClinicalTrials.gov