Overview

This trial is active, not recruiting.

Condition pertussis
Treatment data collection
Sponsor GlaxoSmithKline
Start date March 2014
End date March 2019
Trial size 800 participants
Trial identifier NCT02096276, 201327

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
data collection
Initial and follow-up data will be collected using questionnaires

Primary Outcomes

Measure
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

Eligibility Criteria

Female participants from 12 years up to 64 years old.

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. Pregnancies in which prenatal testing indicates a normal pregnancy would also be excluded because inclusion of such pregnancies could potentially bias results toward a lower overall estimate of risk for defects. Typically pregnancies > 16 weeks gestation will have undergone prenatal testing that can identify whether a child has congenital abnormalities

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.