Dengvaxia US Pregnancy Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dengue Tetravalent Vaccine, Live.
- Who it may be relevant to
- Registry conditions: Dengue Virus Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Puerto Rico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
Overview
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.
Interventions
- Biological Dengue Tetravalent Vaccine, Live
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
Primary outcome measures
- Percentage of pregnant women with maternal adverse events [Time frame: From vaccination until end of follow-up (maximum 22 months after cohort entry)]
- Pecentage of women with obstetrical adverse events [Time frame: From vaccination until 1 month post-delivery]
- Percentage of participants with adverse pregnancy outcome [Time frame: On day of birth]
- Percentage of offsprings with neonatal adverse events [Time frame: From day of birth to 28 days post-birth]
- Percentage of offsprings with infant adverse events [Time frame: From 29 days to 365 days post-birth]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Puerto Rico · 1 center
- Investigational Site — San Juan
Identifiers
NCT: NCT04486638 · DNG00044 · DNG00044 · U1111-1243-6064