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NCT00489970 · ClinicalTrials.gov registry record · Phase 3
Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,954
- Enrollment target
NCT00489970 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,954 participants.
The verdict
NCT00489970, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,954 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with objectives and outcome measures of the extension phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00346073).
Interventions
- PROCEDURE Taking of blood samples
- BIOLOGICAL Boostrix
- BIOLOGICAL Adacel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,954 participants |
| Start Date | 2007-06-01 |
| Est. Completion | 2016-03-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00489970
The ClinicalTrials.gov registry entry for NCT00489970 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,954 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 3 interventions - of which Taking of blood samples is the first listed.
NCT00489970 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00489970 about?
NCT00489970 is a clinical study titled "Persistence Study of GSK Biologicals' Tdap Vaccine 1, 3, 5 and 9 Years Following Administration as an Initial Single Dose in Healthy Young Adults and to Evaluate the Immunogenicity and Safety of Boostrix as a Second Dose of Tdap, When Administered at Year 9". The purpose of this study is to evaluate the persistence of antibodies against all the vaccine antigens 1, 3, 5 and 9 years after an initial vaccination with Tdap, and also to assess immunogenicity and safety of another dose of Boostrix, administered in this study. This protocol posting deals with ...
What is the current status of trial NCT00489970?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,954 participants. The study started on 2007-06-01. Estimated completion is 2016-03-01.
What interventions are being tested in trial NCT00489970?
The interventions under investigation include: Taking of blood samples (PROCEDURE), Boostrix (BIOLOGICAL), Adacel (BIOLOGICAL).
Who is sponsoring clinical trial NCT00489970?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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