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NCT00471081 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
A Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 385
- Enrollment target
- 19
- Study locations
NCT00471081: Completed Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
NCT00471081 is a Phase 2 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 385 participants, below the 469-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (18% lower). The trial reports 19 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00471081, a Phase 2 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 385 participants
- Enrollment target
- 19
- Study locations
Study Summary
The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
Primary Outcome
The cut-off value for the hSBA titers was greater than or equal to (≥) 1:8.
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal vaccine GSK134612
Study Locations (19)
California
- GSK Investigational Site - Antioch
- GSK Investigational Site - Fremont
- GSK Investigational Site - Hayward
- GSK Investigational Site - Madera
- GSK Investigational Site - Santa Rosa
- GSK Investigational Site - Vacaville
Colorado
- GSK Investigational Site - Lakewood
- GSK Investigational Site - Littleton
- GSK Investigational Site - Littleton
- GSK Investigational Site - Westminster
- GSK Investigational Site - Wheat Ridge
Arkansas
- GSK Investigational Site - Benton
- GSK Investigational Site - Little Rock
Pennsylvania
- GSK Investigational Site - Erie
- GSK Investigational Site - Greenville
Alabama
- GSK Investigational Site - Birmingham
Georgia
- GSK Investigational Site - Birmingham
Ohio
- GSK Investigational Site - Canton
Texas
- GSK Investigational Site - Amarillo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 385 participants |
| Start Date | 2007-07-05 |
| Est. Completion | 2008-11-26 |
| Phase | Phase 2 |
What the finished NCT00471081 record still lists
NCT00471081 is an interventional study that assigns participants to a tested intervention. The registered 385 participants enrollment target is mid-sized for trials with a published cap, below the 469-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (18% 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.
NCT00471081 lists 19 locations in 8 states (California, Colorado, Arkansas).
Frequently Asked Questions
What is clinical trial NCT00471081 about?
NCT00471081 is a clinical study titled "Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.". The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.
What is the current status of trial NCT00471081?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 385 participants. The study started on 2007-07-05. Estimated completion is 2008-11-26.
What conditions does trial NCT00471081 study?
This clinical trial studies the following conditions: Infections, Meningococcal.
What interventions are being tested in trial NCT00471081?
The interventions under investigation include: Meningococcal vaccine GSK134612 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00471081?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00471081 being conducted?
This trial has 19 study locations across Alabama, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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