Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
Overview
- Phase
- Not Applicable
- Intervention
- Dengue Tetravalent Vaccine, Live
- Conditions
- Dengue Virus Infection
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Percentage of pregnant women with maternal adverse events
- Status
- Recruiting
- Last Updated
- 3 months ago
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.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion Criteria
- Not provided
Arms & Interventions
Pregnant women and their offspring(s)
Women and their offspring(s) exposed to Dengvaxia during pregnancy
Intervention: Dengue Tetravalent Vaccine, Live
Outcomes
Primary Outcomes
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
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
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
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
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