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

NCT04023708 | Completed

• 2 other identifiers: DNG16U1111-1217-3443
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dengue Virus Infection

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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)

• 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

• 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

Study Arms (1)

Cohort I: CYD-TDV exposed pregnant women and offspring

Pregnant women of any age and their offspring who were inadvertently exposed to CYD-TDV anytime during the pregnancy or in the 30 days preceding their LMP

Drug: CYD-TDV Dengue Vaccine

Interventions

CYD-TDV Dengue Vaccine DRUG

Pharmaceutical form:Solution Route of administration: Intramuscular

Also known as: Dengvaxia®

Cohort I: CYD-TDV exposed pregnant women and offspring

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible pregnant women of any age residing in Paraná who received at least one dose of CYD-TDV during pregnancy or up to 30 days preceding LMP and the offsprings resulting from those pregnancies. The study could also be extended to other regions and states of Brazil.

You may qualify if:

• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Universidade Federal do Paraná Site Number : 1

Curitiba, Paraná, 80010-200, Brazil

Location

Biospecimen

Retention: NONE RETAINED

No biospecimens will be collected from participants, therefore, no biospecimens will be retained

MeSH Terms

Conditions

Dengue

Interventions

Dengue Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 22 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 17, 2019
• Study Start: March 11, 2022
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)