Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03463577 · ClinicalTrials.gov registry record
The Safety of Boostrix Following Routine Immunization of Pregnant Women
A clinical trial of Whooping Cough, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 65,783
- Enrollment target
- 1
- Study location
NCT03463577 is a study of Whooping Cough that has completed, run by GlaxoSmithKline. The registered enrollment target is 65,783 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03463577, a study of Whooping Cough, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 65,783 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study was to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that provided safety information to the public and healthcare providers. This was one of the largest cohorts of pregnant women vaccinated with Boostrix in the U.S. Through partnership between Kaiser Permanente Southern California (KPSC) and the sponsor, GlaxoSmithKline (GSK), information about the safety of maternal vaccination with Boostrix and maternal and infant adverse events (AEs) in a community setting was gained.
Conditions Studied
Interventions
- OTHER Safety assessment following routine immunization with Boostrix
Study Locations (1)
California
- GSK Investigational Site - Pasadena
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65,783 participants |
| Start Date | 2018-04-13 |
| Est. Completion | 2020-08-04 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03463577
The ClinicalTrials.gov registry entry for NCT03463577 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 65,783 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Whooping Cough appearing as the primary indexed condition, and to 1 intervention - of which Safety assessment following routine immunization with Boostrix is the first listed.
NCT03463577 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03463577 about?
NCT03463577 is a clinical study titled "The Safety of Boostrix Following Routine Immunization of Pregnant Women". The purpose of this study was to assess the safety of Boostrix administered on or after the first day of the 27th week of pregnancy by conducting a post-marketing study that provided safety information to the public and healthcare providers. This was one of the largest cohorts of pregnant women vacc...
What is the current status of trial NCT03463577?
This trial is currently completed. The enrollment target is 65,783 participants. The study started on 2018-04-13. Estimated completion is 2020-08-04.
What conditions does trial NCT03463577 study?
This clinical trial studies the following conditions: Whooping Cough.
What interventions are being tested in trial NCT03463577?
The interventions under investigation include: Safety assessment following routine immunization with Boostrix (OTHER).
Who is sponsoring clinical trial NCT03463577?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03463577 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Whooping Cough
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.