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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 270 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00359983
The ClinicalTrials.gov registry entry for NCT00359983 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 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 MenHibrix (Hib-MenCY-TT) is the first listed.
NCT00359983 reports 0 study locations.
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.
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