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Boostrix® Pregnancy Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02096276
Recruitment Status : Active, not recruiting
First Posted : March 26, 2014
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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 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

Condition or disease Intervention/treatment
Pertussis 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
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
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 24, 2014
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Boostrix
U.S. FDA Resources

Group/Cohort Intervention/treatment
Exposed cohort
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.



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Eligible pregnancies reported by patients and HCPs
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096276


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02096276     History of Changes
Other Study ID Numbers: 201327
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by GlaxoSmithKline:
Pregnancy Registry
Boostrix
Women
Cohort
Prospective
Pregnancy outcome
Exploratory