VLA1553-403 Pregnancy Surveillance Study (NCT07414524) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
VLA1553-403 Pregnancy Surveillance Study
200 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency (n,%) of individuals with any outcome (pregnancy and infant health), as described in the protocol.
Timeframe: Study start through study completion, an average of 12 months
2
Frequency (n,%) of specific outcomes (pregnancy and infant health), as described in the protocol.
Timeframe: Study start through study completion, an average of 12 months