Trials / Recruiting
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)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Dengue Tetravalent Vaccine, Live | Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2029-06-30
- Completion
- 2029-06-30
- First posted
- 2020-07-24
- Last updated
- 2026-01-21
Locations
1 site across 1 country: Puerto Rico
Source: ClinicalTrials.gov record NCT04486638. Inclusion in this directory is not an endorsement.