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NCT01641042 · ClinicalTrials.gov registry record · Phase 3
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
A Phase 3 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 86
- Enrollment target
- 16
- Study locations
NCT01641042: Completed Phase 3 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
NCT01641042 is a Phase 3 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 86 participants, below the 512-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (83% lower). The trial reports 16 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641042, a Phase 3 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 86 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
Primary Outcome
Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects \[i.e. pre-vaccination rSBA antibody titers below (\<) 1:8\] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal vaccine GSK134612
Study Locations (16)
California
- GSK Investigational Site - Antioch
- GSK Investigational Site - Daly City
- GSK Investigational Site - Fremont
- GSK Investigational Site - Hayward
- GSK Investigational Site - Oakland
- GSK Investigational Site - Redwood City
- GSK Investigational Site - Roseville
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Santa Clara
- GSK Investigational Site - Santa Rosa
- GSK Investigational Site - Vallejo
North Carolina
- GSK Investigational Site - Durham
- GSK Investigational Site - Durham
Other
- GSK Investigational Site - Brno
- GSK Investigational Site - Hradec Králové
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2012-09-10 |
| Est. Completion | 2015-03-03 |
| Phase | Phase 3 |
What the finished NCT01641042 record still lists
NCT01641042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 512-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Infections, Meningococcal appearing as the primary indexed condition, and to 1 intervention - of which Meningococcal vaccine GSK134612 is the first listed.
NCT01641042 lists 16 locations in 3 states (California, North Carolina, Other).
Frequently Asked Questions
What is clinical trial NCT01641042 about?
NCT01641042 is a clinical study titled "Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects". The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
What is the current status of trial NCT01641042?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 86 participants. The study started on 2012-09-10. Estimated completion is 2015-03-03.
What conditions does trial NCT01641042 study?
This clinical trial studies the following conditions: Infections, Meningococcal.
What interventions are being tested in trial NCT01641042?
The interventions under investigation include: Meningococcal vaccine GSK134612 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01641042?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01641042 being conducted?
This trial has 16 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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