Boostrix® Pregnancy Registry

Completed

Conditions studied: Pertussis

In brief

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

Key facts

Study ID

NCT02096276

Run by

GlaxoSmithKline

People needed

1517

Starts

2014-03-31

Expected to finish

2019-08-02

Last updated by the study team

2020-12-19

Who can join

Age: 12 and older, up to 64. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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