Health TrialsbyHealthPanel

Dengvaxia US Pregnancy Registry

ConditionDengue Virus Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSanofi Pasteur, a Sanofi Company

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Sufficient evidence to confirm the case qualifies as "exposed during pregnancy";

Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dengue Tetravalent Vaccine, Live

    Biological/Vaccine

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

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Pregnant women and their offspring(s)1 intervention

Trial outcomes

Primary outcomes

1

Percentage of pregnant women with maternal adverse events

Maternal adverse events are reported as serious or non-serious

Time frame
From vaccination until end of follow-up (maximum 22 months after cohort entry)
2

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

Time frame
From vaccination until 1 month post-delivery
3

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

Time frame
On day of birth
4

Percentage of offsprings with neonatal adverse events

Neonatal events are reported as serious or non-serious

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi Pasteur, a Sanofi Company

Lead sponsor

Source ClinicalTrials.gov
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