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

Dengue Virus Infection Clinical Trial

Official title:

A Pregnancy Registry to Evaluate the Safety of Dengue Vaccine Among Inadvertently Exposed Pregnant Women and Their Offsprings (DNG16)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023708
• Other study ID #: DNG16
• Secondary ID: U1111-1217-3443
• Status: Completed
• Start date: March 11, 2022
• Est. completion date: March 27, 2023

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary Objective:

To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy, birth, neonatal and infant outcomes. Specifically, the frequency/rates of these outcomes will be: (i) described, and (ii) compared with population-level background incidence rates prior to the introduction of CYD-TDV immunization (i.e., external unvaccinated comparator).

Secondary Objective:

To describe:

• the characteristics of women exposed to CYD-TDV during pregnancy or up to 30 days before the LMP

• the characteristics of CYD-TDV pregnancy exposure with regards to number of doses, dose intervals, and trimester of exposure.

Description:

This is a non -interventional (observational) post authorization safety study (PASS): no vaccine will be administered as part of the study.

This pregnancy registry study is a combination of a retrospective (outcomes occurred before the start of participant enrollment) and prospective (outcomes occurred after the start of participant enrollment) cohort study using active identification and enrollment of pregnant women and their offsprings inadvertently exposed to CYD-TDV during pregnancy or up to 30 days preceding the LMP.

The study period will be from July 2016 (first availability of Paraná's Immunization Registry) to July 2022 (end of last follow-up interview for offsprings), and the participant enrollment period will last approximately 1 year.

Study duration per participant will vary depending on: 1) the stage of pregnancy at the time the participant will be enrolled; 2) whether the participant will be included retrospectively or prospectively. The maximum duration will be 22.5 months (up to 9 months of pregnancy + 42 days post-delivery [puerperium period] + 12 months post-birth).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 27, 2023
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion criteria:

• CYD-TDV exposed pregnant women of any age residing in the 30 municipalities of Paraná where public vaccination campaigns have been offered at the time of their pregnancy exposure, and whose pregnancy exposure was reported to Brazil's AEFI PV database (SI-PNI AEPV).

• Valid contact information (in SI-PNI AEPV).

• Study participants must provide a signed and dated informed consent form (ICF) or assent form (AF) (based on local regulations), and/or a signed and dated ICF by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) if a minor (women who meet the inclusion criteria and provide informed consent to participate and complete the structured interview, but who do not consent to medical record review and/or database linkages will still be included in the study; however, their data will be analyzed separately in a sensitivity analysis).

Exclusion criteria:

• Presence of a major language barrier, medical or psychiatric condition that would prevent a woman from providing informed consent or accurate medical or medication/vaccination histories.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Related Conditions & MeSH terms

• Dengue
• Dengue Virus Infection

Intervention

Drug:
• CYD-TDV Dengue Vaccine
Pharmaceutical form:Solution Route of administration: Intramuscular

Locations

Country	Name	City	State
Brazil	Universidade Federal do Paraná Site Number : 1	Curitiba	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of pregnant women with maternal adverse events	Maternal adverse events defined as all reported adverse events following immunization (serious and non-serious) occurring independent of the pregnancy (e.g., injection site reactions, systemic reactions)	From cohort entry up to 42 days post-end of pregnancy
Primary	Percentage of pregnant women with pregnancy related adverse events	Pregnancy related adverse events defined as adverse event of special interest (AESI)s and other reported adverse events (serious and non-serious) occurring during the pregnancy, labour and delivery, or the puerperium	From cohort entry to up to 42 days post-end of pregnancy
Primary	Percentage of offsprings with adverse birth outcomes	Adverse birth coutcomes defined as study AESIs and other reported adverse events (serious and non-serious) observed or diagnosed at birth	On day of birth (DOB)
Primary	Percentage of offsprings with adverse neonatal events	Adverse neonatal events defined as study AESIs and other reported adverse events (serious and non-serious) occurring between DOB and 28 days post-DOB	From DOB up to 28 days post-birth
Primary	Percentage of offsprings with adverse infant events	Adverse infants events defined as study AESIs and other reported adverse events (serious and non-serious) occurring between day 29 post-birth and 12 months post-birth	From day 29 post-birth up to 12 months post-birth