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Dengvaxia US Pregnancy Registry

NCT04486638 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-01-21

No results posted yet for this study

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

Conditions

  • Dengue Virus Infection

Interventions

BIOLOGICAL

Dengue Tetravalent Vaccine, Live

Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2029-06-30
Completion
2029-06-30

Countries

  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04486638 on ClinicalTrials.gov