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)

Sponsors

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Source Sanofi
Brief 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.

Overall Status Not yet recruiting
Start Date 2021-07-01
Completion Date 2026-08-01
Primary Completion Date 2026-08-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Percentage of pregnant women with maternal adverse events From vaccination until end of follow-up (maximum 22 months after cohort entry)
Pecentage of women with obstetrical adverse events From vaccination until 1 month post-delivery
Percentage of participants with adverse pregnancy outcome On day of birth
Percentage of offsprings with neonatal adverse events From day of birth to 28 days post-birth
Percentage of offsprings with infant adverse events From 29 days to 365 days post-birth
Enrollment 500
Condition
Intervention

Intervention Type: Biological

Intervention Name: Dengue Tetravalent Vaccine, Live

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

Arm Group Label: Pregnant women and their offspring(s)

Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Clinical Sciences & Operations Study Director Sanofi
Overall Contact

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

Phone: 800-633-1610

Phone Ext.: option 6

Email: [email protected]

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Arm Group

Label: Pregnant women and their offspring(s)

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

Acronym DNG00044
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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