Dengvaxia US Pregnancy Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2029-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dengue Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pregnant women and their offspring(s)

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

Dengue Tetravalent Vaccine, Live

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dengue Tetravalent Vaccine, Live

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Investigational Site

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Puerto Rico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.