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.
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2017-31-05
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
GSK Investigational Site
Santo Andre, São Paulo, Brazil, 09060-650
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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