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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: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT02212457 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,063 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (699% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The non-inferiority of the Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant (MenABCWY) vaccine to Meningococcal (group B) multicomponent recombinant adsorbed (Bexsero) vaccine, administered according to 0, 2 month schedule, as measured by hSBA GMTs against N.meningitidis serogroup B test strains at 1 month after the last meningococcal vaccination, is reported. The test strains assessed were Meningit
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 |
What the finished NCT02212457 record still lists
NCT02212457 is an interventional study that assigns participants to a tested intervention. Its 1,063 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (699% higher).
The record links to 0 conditions, and to 4 interventions - of which Saline Placebo is the first listed.
NCT02212457 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02212457's enrollment target sits among peer trials
1,063 24th of 2000 higher than 1,977 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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