Dengvaxia US Pregnancy Registry (NCT04486638) | Clinical Trial Compass
RecruitingNot Applicable
Dengvaxia US Pregnancy Registry
Puerto Rico500 participantsStarted 2023-01-01
Plain-language summary
The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.
Reports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:
* Sufficient evidence to confirm the case qualifies as "exposed during pregnancy";
* Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Percentage of pregnant women with maternal adverse events
Timeframe: From vaccination until end of follow-up (maximum 22 months after cohort entry)
2
Pecentage of women with obstetrical adverse events
Timeframe: From vaccination until 1 month post-delivery
3
Percentage of participants with adverse pregnancy outcome
Timeframe: On day of birth
4
Percentage of offsprings with neonatal adverse events
Timeframe: From day of birth to 28 days post-birth
5
Percentage of offsprings with infant adverse events