RecruitingNCT04486638
Dengvaxia US Pregnancy Registry
Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
Sponsor
Sanofi Pasteur, a Sanofi Company
Enrollment
500 participants
Start Date
Jan 1, 2023
Study Type
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
BIOLOGICALDengue Tetravalent Vaccine, Live
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04486638