Last updated: 01/28/2022 08:10:06
Boostrix® Pregnancy Registry
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: 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)
Secondary outcomes:
Not applicable
Interventions:
Other: Data collection
Enrollment:
1517
Observational study model:
Cohort
Primary completion date:
2019-02-08
Time perspective:
Prospective
Clinical publications:
Anastasia Kuznetsova, Maria Angeles Ceregido, Anne Jourquin, Laura Campora, Fernanda Tavares da Silva . Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Vaccine. 2022;ePublished:
DOI: http://dx.doi.org/ https://doi.org/10.1016/j.vaccine.2021.12.050
Medical condition
Pertussis
Product
GSK2647153A, SB263855, SB776423
Collaborators
Not applicable
Study date(s)
March 2014 to August 2019
Type
Observational
Phase
4
Participation criteria
Sex
Female
Age
12 - 64 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
A subject will be included in the Registry if all of the following criteria are met:
Exclusion criteria:
- 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.
Data from registered subjects will not be included in the analyses if the following criterion is met:
Trial location(s)
Location
GSK Investigational Site
Research Triangle Park, North Carolina, United States, 27709-3398
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol and statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-02-08
Actual study completion date
2019-02-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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