Status:
RECRUITING
Dengvaxia US Pregnancy Registry
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Dengue Virus Infection
Eligibility:
All Genders
Brief 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
Detailed Description
Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04486638
Start Date
January 1 2023
End Date
June 30 2029
Last Update
December 2 2024
Active Locations (1)
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1
Investigational Site
San Juan, Puerto Rico