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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00489970 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,954 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (153% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Anti-D cut-off was defined as ≥ 0.1 International Units per milliliter (IU/mL) determined with Enzyme-linked Immunosorbent Assay (ELISA)
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 |
What the finished NCT00489970 record still lists
NCT00489970 is an interventional study that assigns participants to a tested intervention. Its 1,954 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (153% higher).
The record links to 0 conditions, and to 3 interventions - of which Taking of blood samples is the first listed.
NCT00489970 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00489970's enrollment target sits among peer trials
1,954 107th of 2000 higher than 1,894 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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