Last updated: 09/05/2019 12:10:33

A post-marketing, observational, retrospective study to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.

GSK study ID
203153
See study documents
Clinicaltrials.gov ID
NCT02757950
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered during pregnancy in a maternal immunization program in Brazil.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects reporting gestational diabetes

Timeframe: At week 27 of pregnancy

Number of subjects reporting pregnancy-related hypertension

Timeframe: At week 27 of pregnancy

Number of subjects reporting pregnancy hemorrhage

Timeframe: At week 27 of pregnancy

Number of subjects with pre-specified neonate-related outcomes resulting in preterm birth

Timeframe: 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

Timeframe: At week 27 of pregnancy

Secondary outcomes:

Number of subjects reporting pregnancy-related adverse events (AEs) of interest/neonate-related events up to delivery

Timeframe: At week 27 of pregnancy

Number of subjects reporting cases of congenital anomalies in the neonates

Timeframe: From week 27 of pregnancy up to birth

Number of subjects with pregnancy-related AEs and birth outcomes per calendar year

Timeframe: At week 27 of pregnancy

Interventions:
  • Biological/vaccine: Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
    • Enrollment:
    2462
    Primary completion date:
    2017-31-05
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Sancovski M et al. (2019) 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. 1-9. doi: 10.1080/21645515.2019.1627161. [Epub ahead of print].
    Medical condition
    Diphtheria
    Product
    GSK2647153A
    Collaborators
    Not applicable
    Study date(s)
    July 2016 to May 2017
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18 - 45 years
    Accepts healthy volunteers
    No
    • 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 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).
    Inclusion and exclusion 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Santo Andre, São Paulo, Brazil, 09060-650
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2017-31-05
    Actual study completion date
    2017-31-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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