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NCT00614614 · ClinicalTrials.gov registry record · Phase 3
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
A Phase 3 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,558
- Enrollment target
- 20
- Study locations
NCT00614614: Completed Phase 3 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
NCT00614614 is a Phase 3 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,558 participants, above the 301-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (418% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00614614, a Phase 3 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,558 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.
Primary Outcome
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Conditions Studied
Interventions
- BIOLOGICAL Pediarix®
- BIOLOGICAL GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
- BIOLOGICAL GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix)
- BIOLOGICAL Infanrix®
- BIOLOGICAL ActHIB®
Study Locations (20)
Arkansas
- GSK Investigational Site - Benton
- GSK Investigational Site - Fayetteville
- GSK Investigational Site - Jonesboro
- GSK Investigational Site - Little Rock
California
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Fresno
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - West Covina
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Dothan
Florida
- GSK Investigational Site - Plantation
- GSK Investigational Site - West Palm Beach
Georgia
- GSK Investigational Site - Marietta
- GSK Investigational Site - Woodstock
Iowa
- GSK Investigational Site - Des Moines
- GSK Investigational Site - West Des Moines
Idaho
- GSK Investigational Site - Nampa
Kansas
- GSK Investigational Site - Arkansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,558 participants |
| Start Date | 2008-02-13 |
| Est. Completion | 2009-09-17 |
| Phase | Phase 3 |
What the finished NCT00614614 record still lists
NCT00614614 is an interventional study that assigns participants to a tested intervention. Its 1,558 participants enrollment target places it among the larger protocols in the corpus, above the 301-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (418% higher).
The record links to 1 condition, with Infections, Meningococcal appearing as the primary indexed condition, and to 5 interventions - of which Pediarix® is the first listed.
NCT00614614 names 20 study sites across 9 states, led by Arkansas, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT00614614 about?
NCT00614614 is a clinical study titled "Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014". The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vacci...
What is the current status of trial NCT00614614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,558 participants. The study started on 2008-02-13. Estimated completion is 2009-09-17.
What conditions does trial NCT00614614 study?
This clinical trial studies the following conditions: Infections, Meningococcal.
What interventions are being tested in trial NCT00614614?
The interventions under investigation include: Pediarix® (BIOLOGICAL), GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix) (BIOLOGICAL), GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) (BIOLOGICAL), Infanrix® (BIOLOGICAL), ActHIB® (BIOLOGICAL).
Who is sponsoring clinical trial NCT00614614?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00614614 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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