Dengvaxia US Pregnancy Registry

Study Overview
=================
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.

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

Conditions
-----------------
Dengue Virus Infection

Intervention / Treatment
-----------------
* Biological: Dengue Tetravalent Vaccine, Live


Participation Criteria
=================
Eligibility 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women and their offspring(s)<br>Women and their offspring(s) exposed to Dengvaxia during pregnancy | Biological: Dengue Tetravalent Vaccine, Live<br>* Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of offsprings with infant adverse events | Infant events are reported as serious or non-serious | From 29 days to 365 days post-birth |