Dengue Virus InfectionDNG00044NCT04486638
Dengvaxia US Pregnancy Registry
An observational study of Dengue Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in Puerto Rico.
Trial 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 Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dengue Virus Infection
- What is being tested?
- Dengue Tetravalent Vaccine, Live
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 500 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Jan 2023to 30 Jun 2029
- How long will I take part?
- 22 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dengvaxia US Pregnancy Registry HelpLine contact
Trial Transparency email recommended (Toll free number for US & Canada) contact
About this study
Official title: Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
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
Read the 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.
- Conditions
- Dengue Virus Infection
- Being tested
- Dengue Tetravalent Vaccine, Live
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue Tetravalent Vaccine, LiveBiological
Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women and their offspring(s) | Women and their offspring(s) exposed to Dengvaxia during pregnancy Receives: Biological: Dengue Tetravalent Vaccine, Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pregnant women with maternal adverse events
Maternal adverse events are reported as serious or non-serious
Measured: From vaccination until end of follow-up (maximum 22 months after cohort entry)
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
Measured: From vaccination until 1 month post-delivery
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
Measured: On day of birth
Percentage of offsprings with neonatal adverse events
Neonatal events are reported as serious or non-serious
Measured: From day of birth to 28 days post-birth
Percentage of offsprings with infant adverse events
Infant events are reported as serious or non-serious
Measured: From 29 days to 365 days post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start1 Jan 2023
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dengue Virus InfectionStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 22 Months
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486638
- Sponsor's protocol ID
- DNG00044
- Other IDs
- DNG00044, U1111-1243-6064
- Acronym
- DNG00044
- Status last verified
- Jan 2026
- First submitted
- 22 Jul 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
- ClinicalTrials.gov ID
- NCT04486638
- Acronym / sponsor ID
- DNG00044 / DNG00044
- Conditions
- Dengue Virus Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 22 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women and their offspring(s) | – | Biological: Dengue Tetravalent Vaccine, LiveWomen and their offspring(s) exposed to Dengvaxia during pregnancy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengue Tetravalent Vaccine, LivePharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous | Biological | Pregnant women and their offspring(s) |
Primary outcome
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 neonatal adverse events
Time frame: From day of birth to 28 days post-birth
Neonatal events are reported as serious or non-serious
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dengvaxia US Pregnancy Registry HelpLine contact
Trial Transparency email recommended (Toll free number for US & Canada) contact
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dengue Virus Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dengvaxia US Pregnancy Registry HelpLine (1-800-822-2463), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pregnant women with maternal adverse events (time frame: From vaccination until end of follow-up (maximum 22 months after cohort entry)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.