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NCT00346073 · ClinicalTrials.gov registry record · Phase 3

Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
2,337
Enrollment target

NCT00346073 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,337 participants.

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The verdict

NCT00346073, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
2,337 participants
Enrollment target

Study Summary

GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data in support of extending the age range for Boostrix vaccine to include adults 19-64 years of age.

Interventions

  • BIOLOGICAL Boostrix™
  • BIOLOGICAL ADACEL®

Trial Details

FieldValue
Enrollment Target 2,337 participants
Start Date 2006-07-13
Est. Completion 2007-03-07
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT00346073

The ClinicalTrials.gov registry entry for NCT00346073 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,337 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 0 conditions, and to 2 interventions - of which Boostrix™ is the first listed.

NCT00346073 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00346073 about?

NCT00346073 is a clinical study titled "Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years". GSK Biologicals' dTpa vaccine has recently been approved by the US Food and Drug Administration (FDA) for booster vaccination of adolescents aged 10 to 18 years. The ACIP has recently issued provisional recommendations for universal adult Tdap vaccination. The current study will provide pivotal data...

What is the current status of trial NCT00346073?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,337 participants. The study started on 2006-07-13. Estimated completion is 2007-03-07.

What interventions are being tested in trial NCT00346073?

The interventions under investigation include: Boostrix™ (BIOLOGICAL), ADACEL® (BIOLOGICAL).

Who is sponsoring clinical trial NCT00346073?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.