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NCT00359983 · ClinicalTrials.gov registry record · Phase 3
Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT00359983: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00359983 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 270 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359983, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129). This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.
Primary Outcome
Results up to 5 years after the fourth dose are presented.
Interventions
- BIOLOGICAL MenHibrix (Hib-MenCY-TT)
- BIOLOGICAL Hib conjugate vaccine (ActHIB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2006-09 |
| Est. Completion | 2011-05 |
| Phase | Phase 3 |
What the finished NCT00359983 record still lists
NCT00359983 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which MenHibrix (Hib-MenCY-TT) is the first listed.
NCT00359983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00359983 about?
NCT00359983 is a clinical study titled "Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB". This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \&...
What is the current status of trial NCT00359983?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2006-09. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00359983?
The interventions under investigation include: MenHibrix (Hib-MenCY-TT) (BIOLOGICAL), Hib conjugate vaccine (ActHIB) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00359983?
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 NCT00359983's enrollment target sits among peer trials
270 1217th of 2000 higher than 781 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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