Dengvaxia US Pregnancy Registry

Clinical Trial 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. ;

Study Design

See also
	Status	Clinical Trial	Phase
	Completed	`NCT04023708` - Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy
	Completed	`NCT04170140` - Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

See also

Status

Clinical Trial

Phase

Completed

NCT04023708 - Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy

Completed

NCT04170140 - Study on Prescribers' Knowledge and Understanding of Safety Messages Following Dengvaxia® Product Information Update

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04486638
Study type	Observational [Patient Registry]
Source	Sanofi
Contact	Dengvaxia US Pregnancy Registry HelpLine
Phone	1-800-822-2463
Status	Recruiting
Phase
Start date	September 7, 2022
Completion date	November 2026

Dengvaxia US Pregnancy Registry — DNG00044

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms