Boostrix® Pregnancy Registry
The purpose of this Registry is to detect and describe any abnormal pregnancy outcomes, including teratogenicity, in females intentionally or unintentionally exposed to Boostrix during their pregnancies. The Registry requires voluntary, prospective reporting of eligible pregnancies by patients and health care providers (HCPs). Data such as vaccination with Boostrix during pregnancy or within 28 days preceding conception, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy will be collected prospectively.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Boostrix® Pregnancy Registry: a Prospective, Exploratory, Cohort Study to Detect and Describe Any Abnormal Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix® During Pregnancy or Within 28 Days Preceding Conception|
- Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix during pregnancy or within 28 days preceding conception [ Time Frame: Up to 12 months after EDD ] [ Designated as safety issue: No ]
|Study Start Date:||March 2014|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Pregnant US women, vaccinated with Boostrix during pregnancy or within 28 days preceding conception and volunteering to take part in the Pregnancy Registry before the outcome of the pregnancy is known.
Other: Data collection
Initial and follow-up data will be collected using questionnaires
The Registry was originally initiated on 03 May 2005, as part of a program of enhanced pharmacovigilance. Following new European Union Pharmacovigilance legislation, pregnancy registries are to be considered as post-authorization safety studies (PASS). The ongoing Registry will therefore be converted into a PASS study.
Exposed pregnancies reported to the Registry before the transition into a PASS (between 03 May 2005 and Q1 2014), from which data were collected and analyzed prospectively, will also be included in the analyses.
Some pregnancy exposures may be reported after pregnancy outcome has been identified (retrospective reports). The Registry will capture retrospective reports, but these reports will not be included in the analyses of prospective reports.
Pregnancy outcome data will be collected using questionnaires within 3 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births) to ascertain the presence of birth defects not diagnosed before, from Q1 2014 to Q4 2018.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02096276
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|