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

SexALL

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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.

What they're measuring

Percentage of pregnant women with maternal adverse events

Timeframe: From vaccination until end of follow-up (maximum 22 months after cohort entry)

Pecentage of women with obstetrical adverse events

Timeframe: From vaccination until 1 month post-delivery

Percentage of participants with adverse pregnancy outcome

Timeframe: On day of birth

Percentage of offsprings with neonatal adverse events

Timeframe: From day of birth to 28 days post-birth

Percentage of offsprings with infant adverse events

Timeframe: From 29 days to 365 days post-birth

Trial details

NCT IDNCT04486638

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2029-06-30

Contact for this trial

Dengvaxia US Pregnancy Registry HelpLine

1-800-822-2463

View on ClinicalTrials.gov More Dengue Virus Infection trials