N/A
N=305
Boostrix® Pregnancy Registry
Pertussis
Bottom Line
View on ClinicalTrials.gov: NCT02096276 ↗Enrolled (actual)
305
Serious AEs
1.3%
Results posted
Dec 2020
Primary outcome: Primary: 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. — 244; 33; 3; 16 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Data collection (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
244; 33; 3; 16; 3; 1 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02096276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.