A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.

NCT02757950 | Completed Results

• 1 other identifier: 203153
• Study Type: observational
• Target: 2,462
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria

Keywords

exposed and unexposed cohorts; post-marketing, maternal immunization; neonate related Adverse Events; Congenital anomaly; RefortrixTM; Pregnancy related Adverse Events

Outcome Measures

Primary Outcomes (5)

• Number of Subjects Reporting Gestational Diabetes

  Gestational diabetes was defined as: Onset or first recognition of abnormal glucose tolerance during pregnancy (the diagnosis is based on administration of glucose challenge test at 24-28 weeks of gestation). Includes Class A1: Euglycaemia achieved with diet and/or exercise and Class A2: Euglycaemia achieved with medication.

  After week 27 of pregnancy

• Number of Subjects Reporting Pregnancy-related Hypertension, Pre-eclampsia, Eclampsia, and HELLP Syndrome

  Pregnancy-related hypertension is defined as: Blood pressure systolic higher than (\>) 140 and/or diastolic \> 90 millimetre of mercury (mmHg), documented in at least two separate measurements after 20 weeks of gestation, without proteinuria or other stigmata of pre-eclampsia, and returning to normal post-partum. Hypertension usually resolves by 12 weeks post-partum, included pre-eclampsia, eclampsia and haemolysis elevated liver enzymes low platelet (HELLP) Syndrome for this study.

  After week 27 of pregnancy

• Number of Subjects Reporting Pregnancy Hemorrhage

  Pregnancy vaginal hemorrhage is defined as: excessive blood loss after delivery i.e. estimated blood loss in excess of 500 milliliters (ml) after vaginal delivery and estimated blood loss in excess of 1000 ml after Caesarean delivery. The other symptoms are higher than or equal to (≥) 10 percent (%) drop in hematocrit, need for blood transfusion, symptomatic hypotension, dizziness, pallor and oliguria. Vaginal or intrauterine hemorrhage that encompasses antepartum (i.e. bleeding from the genital tract after 24 weeks of gestation), intrapartum, and postpartum bleeding (i.e. within 24 hours post-delivery). A major obstetric hemorrhage is defined as blood loss from uterus or genital tract \>1500 ml or a decrease.

  After week 27 of pregnancy

• Number of Subjects With Pre-specified Neonate-related Outcomes Resulting in Preterm Birth

  Preterm birth is defined as: Birth before 37 weeks of gestation.

  From week 27 up to week 37 of pregnancy

• Number of Subjects With Pre-specified Neonate-related Outcomes, Resulting in Neonates Small for Their Gestational Age

  Small for gestational age is defined as: Birth weight less than (\<) 10% for infants of same gestational age and gender in same population.

  After week 27 of pregnancy

Secondary Outcomes (3)

• Number of Subjects Reporting Pregnancy-related Adverse Events (AEs) of Interest/Neonate-related Events up to Delivery

  After week 27 of pregnancy

• Number of Subjects Reporting Cases of Congenital Anomalies in the Neonates

  From week 27 of pregnancy up to birth

• Number of Subjects With Pregnancy-related AEs and Birth Outcomes Per Calendar Year

  After week 27 of pregnancy

Study Arms (2)

Exposed cohort

Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) from May 2015 and who received one dose of Refortrix during 27 to 36 weeks of pregnancy (or as late as 20 days before delivery due date).

Biological: Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]

Unexposed cohort

Women, 18-45 years of age at the time of pregnancy, who delivered in the hospital (study centre) before implementation of the maternal immunization program in Brazil in September 2014 and who did not receive Tdap vaccination during pregnancy.

Biological: Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]

Interventions

Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)] BIOLOGICAL

Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.

Exposed cohort; Unexposed cohort

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Santo André, São Paulo, 09060-650, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31216218 BACKGROUND

MeSH Terms

Conditions

Diphtheria; Congenital Abnormalities

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: GSK Clinical Trials
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

877-379-3718

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 2, 2016
• Study Start: July 14, 2016
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2017
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)