201327 - 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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective study

Study drug and medical condition

• Name of medicine, other:
  Boostrix
• Medical condition to be studied:
  Pertussis

Population studied

• Short description of the study population:
  The study focused on women vaccinated with Boostrix against tetanus, diphtheria, and pertussis during pregnancy or within 28 days of conception in the US.; 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.; ; 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.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  • To describe the characteristics of registered pregnancies (women vaccinated with Boostrix during pregnancy or within 28 days preceding conception) with any abnormal pregnancy outcomes. • To assess the proportion of registered pregnancies (women vaccinated with Boostrix during pregnancy or within 28 days preceding conception) with any abnormal pregnancy outcomes.
• Outcomes:
  Occurrence of any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with Boostrix during pregnancy or within 28 days preceding conception. Pregnancy outcomes are further categorized as: 1) live births, 2) spontaneous abortions (i.e. pregnancy losses), 3) Elective/induced abortions and 4) Fetal deaths/Stillbirths.
• Data analysis plan:
  Pregnancy outcomes are stratified by the trimester of exposure, with an additional stratum for preconception exposure with no subsequent administration of vaccine during pregnancy. Reports of multiple exposures during a pregnancy (i.e. multiple administrations of Boostrix) are classified by the earliest trimester of exposure. When exposure occurs before and after conception, the exposure is classified by the dose administered after conception. The calculations of risk for birth defects are made by dividing the number of infants with birth defects by the total number of infants with and without birth defects. Given the descriptive nature of this study, confidence intervals will not be calculated. The outcomes of the study will be assessed against known rates from an external reference group for the likelihood of a safety signal warranting further investigation.

Documents

Study results

gsk-201327-clinical-study-report-redact

Study publications

Anastasia Kuznetsova, Maria Angeles Ceregido, Anne Jourquin, Laura Campora, Fer…