CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,517 enrolled
Drug / intervention
Data collectionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02096276
NCT02096276N/ACompleted
CompareCT.gov

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

GlaxoSmithKline·observational·Posted Mar 26, 2014·Updated Dec 19, 2020

In Brief

An observational study evaluating Data collection for Pertussis. Completed, enrolled 1,517 participants across 1 site.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPertussis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 26, 2014
Enrollment StartMar 31, 2014
Primary CompletionAug 2, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.3 years ago

Interventions

Data collectionother

Initial and follow-up data will be collected using questionnaires.