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NCT Number: NCT04486638

Dengvaxia US Pregnancy Registry

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

Recruiting

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Key information

Conditions

Dengue Virus Infection Arbovirus Infections Dengue Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site

San Juan, Puerto Rico

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dengue Tetravalent Vaccine, Live

Biological

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

Primary outcomes

  1. Percentage of pregnant women with maternal adverse events

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

    Maternal adverse events are reported as serious or non-serious

  2. Pecentage of women with obstetrical adverse events

    Time frame: From vaccination until 1 month post-delivery

    Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious

  3. Percentage of participants with adverse pregnancy outcome

    Time frame: On day of birth

    Adverse pregnancy outcomes include ectopic pregnancy, elective/induced abortion with no fetal defect(s) or fetus status unknown, elective/induced abortion with fetal defect(s), spontaneous abortion/miscarriage (<20 weeks), stillbirth/fetal death at 20-27 weeks, fetal death at ≥28 weeks, and fetal death due to maternal death

  4. Percentage of offsprings with neonatal adverse events

    Time frame: From day of birth to 28 days post-birth

    Neonatal events are reported as serious or non-serious

  5. Percentage of offsprings with infant adverse events

    Time frame: From 29 days to 365 days post-birth

    Infant events are reported as serious or non-serious

Study contacts

Contact information is provided by the study sponsor or research team.

Dengvaxia US Pregnancy Registry HelpLine

CONTACT

1-800-822-2463

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)

Acronym: DNG00044

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Jul 24, 2020
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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