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NCT02212457 · ClinicalTrials.gov registry record · Phase 2
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,063
- Enrollment target
NCT02212457 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,063 participants.
The verdict
NCT02212457, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,063 participants
- Enrollment target
Study Summary
The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give the flexibility for the national vaccination program by showing the safety and immunogenicity of MenABCWY administrated according to four different vaccination schedules and additionally to evaluate a potential benefit of the 3-dose vaccination series.
Interventions
- OTHER Saline Placebo
- BIOLOGICAL Havrix
- BIOLOGICAL MenABCWY
- BIOLOGICAL Bexsero
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,063 participants |
| Start Date | 2014-08-21 |
| Est. Completion | 2016-03-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02212457
The ClinicalTrials.gov registry entry for NCT02212457 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,063 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 4 interventions - of which Saline Placebo is the first listed.
NCT02212457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02212457 about?
NCT02212457 is a clinical study titled "Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents". The main purposes for conducting the study are firstly to assess immunological non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine (Bexsero™) in terms of hSBA GMTs at one month...
What is the current status of trial NCT02212457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,063 participants. The study started on 2014-08-21. Estimated completion is 2016-03-03.
What interventions are being tested in trial NCT02212457?
The interventions under investigation include: Saline Placebo (OTHER), Havrix (BIOLOGICAL), MenABCWY (BIOLOGICAL), Bexsero (BIOLOGICAL).
Who is sponsoring clinical trial NCT02212457?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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