Boostrix® Pregnancy Registry
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|ClinicalTrials.gov Identifier: NCT02096276|
Recruitment Status : Recruiting
First Posted : March 26, 2014
Last Update Posted : March 20, 2018
|Condition or disease||Intervention/treatment|
|Pertussis||Other: Data collection|
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 in Q1 2014.
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 2 months of the estimated date of delivery (EDD) and approximately 6 months and 12 months after the EDD (for all live births for whom the contact details of their HCP will be available) to ascertain the presence of birth defects not diagnosed before, from Q1 2014 to Q3 2019.
|Study Type :||Observational|
|Estimated Enrollment :||800 participants|
|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|
|Actual Study Start Date :||March 31, 2014|
|Estimated Primary Completion Date :||August 2, 2019|
|Estimated Study Completion Date :||August 2, 2019|
A group of subjects who voluntarily report vaccine-exposed pregnancies to the registry.
Other: Data collection
Initial and follow-up data will be collected using questionnaires.
- Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix. [ Time Frame: From 28 days preceding conception until birth ]Pregnancy outcomes include spontaneous abortion (pregnancy loss before 22 weeks gestation), fetal deaths/stillbirths (loss at or after 22 weeks gestation), elective/induced abortions and live births.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096276
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|United States, North Carolina|
|GSK Investigational Site||Recruiting|
|Research Triangle Park, North Carolina, United States, 27709-3398|
|Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com|
|Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|