Boostrix® Pregnancy Registry
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 12 - 64 |
| Updated: | 4/17/2018 |
| Start Date: | March 31, 2014 |
| End Date: | August 2, 2019 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
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
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 in the US. 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
including teratogenicity, in females intentionally or unintentionally exposed to Boostrix
during their pregnancies in the US. 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
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.
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.
Inclusion Criteria:
A subject will be included in the Registry if all of the following criteria are met:
- Exposure to vaccine occurs during pregnancy or within 28 days preceding conception.
- Subject is a US resident.
- A HCP is identified (name, address and phone number).
- Subject can be identified (by GSK or HCP).
Data from registered subjects will be included in the analyses if the following criterion
is met:
• Pregnancy is ongoing and the outcome is unknown.
Exclusion Criteria:
Data from registered subjects will not be included in the analyses if the following
criterion is met:
• Outcome of pregnancy is known at the time of initial report. Types of known outcomes
include prenatal testing reports in which the results are abnormal or outside the reference
range, indicating possible abnormality in the fetus. Typically, pregnancies > 16 weeks
gestation will have undergone prenatal testing that can identify whether a child has
congenital abnormalities.
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