Dengvaxia US Pregnancy Registry (DNG00044)

Sanofi

Status: Enrolling

Conditions: Dengue Virus Infection

Treatments: Biological: Dengue Tetravalent Vaccine, Live

Study type: Observational

Funder types: Industry

Identifiers

NCT04486638

U1111-1243-6064 (Registry Identifier)

DNG00044

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

500 participants in 1 patient group

Pregnant women and their offspring(s)

Description:

Women and their offspring(s) exposed to Dengvaxia during pregnancy

Treatment:

Biological: Dengue Tetravalent Vaccine, Live