Clinical trial NCT02757950: A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Official title: A Post-marketing, Observational, Retrospective, Cohort Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Keywords: exposed and unexposed cohorts
post-marketing, maternal immunization
neonate related Adverse Events
Congenital anomaly
RefortrixTM
Pregnancy related Adverse Events
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 2462
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who delivered in the study centre from May 2015 onwards will be considered as potentially exposed and those who delivered before September 2014 will be considered as potentially unexposed

Brief summary: The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.

Detailed description: In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during pregnancy as part of the National immunization program in Brazil will be assessed by comparing the risk of pre-defined adverse events before and after introduction of the RefortrixTM (Tdap) maternal immunization program.

Eligibility criteria: Inclusion Criteria:

* Subjects between 18 and 45 years of age at the time of pregnancy under consideration for the study, who deliver in the study centre.
* Residents of the study area
* Subjects who were compliant with the routine antenatal care including at least one ultrasound assessment report early in the pregnancy.
* Subjects with the complete and relevant medical records available.

Inclusion criteria for the Exposed cohort:

* Subjects who received one dose of Refortrix vaccine in the recommended time period between 27 and 36 completed weeks of pregnancy (or as late as 20 days before delivery due date) as part of the maternal immunization program in Brazil, and according to the program recommendations from May 2015 onwards.
* Subjects with appropriate vaccination records.

Inclusion criteria for the Unexposed cohort:

* Subjects who had delivered in the same hospital (study centre) before 01 September 2014 (September 2012-August 2014) and who did not receive Tdap vaccination during pregnancy to the best knowledge of the investigator.

Exclusion Criteria:

* Subjects who have been transferred to other specialised centres, where their medical records would be inaccessible for the study (private clinics, psychiatric or prison hospitals, other state hospitals, etc).

Primary outcomes:
measure: Number of Subjects Reporting Gestational Diabetes
timeFrame: After week 27 of pregnancy
measure: Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome
timeFrame: After week 27 of pregnancy
measure: Number of Subjects Reporting Pregnancy Hemorrhage
timeFrame: After week 27 of pregnancy
measure: Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth
timeFrame: From week 27 up to week 37 of pregnancy
measure: Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age
timeFrame: After week 27 of pregnancy
Secondary outcomes:
measure: Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery
timeFrame: After week 27 of pregnancy
measure: Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates
timeFrame: From week 27 of pregnancy up to birth
measure: Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year
timeFrame: After week 27 of pregnancy
Other outcomes:
Locations:
city: Santo Andre
country: Brazil
facility: GSK Investigational Site
state: São Paulo
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Sancovski M, Mesaros N, Feng Y, Ceregido MA, Luyts D, De Barros E. Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study. Hum Vaccin Immunother. 2019;15(12):2873-2881. doi: 10.1080/21645515.2019.1627161. Epub 2019 Jun 20.