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: Completed study of Whooping Cough, sponsored by GlaxoSmithKline.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The incidence rate (per 1000) of maternal adverse events was calculated as the total number of adverse events in the numerator and the total person-years at risk in the denominator. Every unexposed woman was assigned an index date that is determined by the number of days from pregnancy start to the Boostrix vaccination date of her matched exposed woman. The same number of days calculated in the exposed woman was added to the pregnancy start of the unexposed woman to identify her index date. The
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 |
What the finished NCT03463577 record still lists
NCT03463577 is an observational study that tracks outcomes without assigning an intervention. Its 65,783 participants enrollment target places it among the larger protocols in the corpus.
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 a single indexed study location in 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.
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04473833 · 65,000 participants · NA
Transvaginal Ultrasonography as a Screening Method for Ovarian Cancer
- NCT00009633 · 68,000 participants
Follow-up Visit of High Risk Infants
- NCT06903897 · 68,000 participants · NA
Social Needs Screening and Chronic Diseases Study (WE CARE)
- NCT05128006 · 63,200 participants
Direct-to-patient Teledermatology and Computer-assisted Diagnosis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI