Boostrix® Pregnancy Registry

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

Study Overview

• Status: Completed
• Conditions: Pertussis
• Intervention / Treatment: Other: Data collection

Detailed 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 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
• Enrollment (Actual): 1517

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709-3398
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Eligible pregnancies reported by patients and HCPs

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposure Group_Prospective; Pregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and prospective (i.e., registration to registry is done before the outcome of the pregnancy is known)	Other: Data collection; Initial and follow-up data will be collected using questionnaires.
Exposure Group_Retrospective; Pregnant women within the United States (US) who are exposed to Boostrix vaccine during pregnancy or within 28 days preceding conception and with known pregnancy outcomes. Reporting of exposed pregnancies is voluntary and retrospective (i.e., pregnancy outcome is already known at the time of registration to Registry)	Other: Data collection; Initial and follow-up data will be collected using questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Known Pregnancy Outcomes, by Type of Pregnancy Outcomes in Women Intentionally or Unintentionally Vaccinated With Boostrix During Pregnancy or Within 28 Days Preceding Conception.	Pregnancy outcomes included live births, spontaneous abortions (pregnancy loss <22 weeks of gestation), stillbirths (pregnancy loss ≥22 weeks of gestation) and elective terminations. Each pregnancy outcome was further classified according to the presence or absence of a birth defect.	Data collected between 03 May 2005 to 02 August 2019: For each subject from date of registration until the pregnancy outcome documentation date (Exposure_Prospective group) or at pregnancy outcome documentation date (Exposure_Retrospective group)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2014
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: March 21, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: November 23, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Women; Cohort; Prospective; Boostrix; Pregnancy Registry; Exploratory; Pregnancy outcome
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Whooping Cough
• Other Study ID Numbers: 201327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No