Dengvaxia US Pregnancy Registry

Dengue Virus Infection Clinical Trial

— DNG00044  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04486638
• Other study ID #: DNG00044
• Status: Recruiting
• Start date: September 7, 2022
• Est. completion date: November 2026

Study information

• Verified date: August 2023
• Source: Sanofi
• Contact: Dengvaxia US Pregnancy Registry HelpLine
• Phone: 1-800-822-2463
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dengue Virus Infection

Intervention

Biological:
• Dengue Tetravalent Vaccine, Live
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous

Locations

Country	Name	City	State
Puerto Rico	Investigational Site	Puerto Rico

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of pregnant women with maternal adverse events	Maternal adverse events are reported as serious or non-serious	From vaccination until end of follow-up (maximum 22 months after cohort entry)
Primary	Pecentage of women with obstetrical adverse events	Obstetrical adverse events are collected during pregnancy, labour, delivery and puerperium, and are reported as serious or non-serious	From vaccination until 1 month post-delivery
Primary	Percentage of participants with adverse pregnancy outcome	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	On day of birth
Primary	Percentage of offsprings with neonatal adverse events	Neonatal events are reported as serious or non-serious	From day of birth to 28 days post-birth
Primary	Percentage of offsprings with infant adverse events	Infant events are reported as serious or non-serious	From 29 days to 365 days post-birth