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NCT01165242 · ClinicalTrials.gov registry record · Phase 2
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
A Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,013
- Enrollment target
- 20
- Study locations
NCT01165242: Completed Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
NCT01165242 is a Phase 2 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,013 participants, above the 379-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (167% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01165242, a Phase 2 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,013 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.
Primary Outcome
Vaccine response was defined as: * for initially seronegative subjects \[with hSBA titer below (\<) 1:4\]: post-vaccination antibody titer greater than or equal to (≥) 1:8 one month after vaccination; * for initially seropositive subjects (with hSBA titer ≥ 1:4): post-vaccination antibody titer ≥ 4-fold the pre-vaccination antibody titer one month after vaccination.
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal vaccine GSK 134612
- BIOLOGICAL Menactra®
Study Locations (20)
California
- GSK Investigational Site - Paramount
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Sacramento
- GSK Investigational Site - Santa Rosa
Georgia
- GSK Investigational Site - Marietta
- GSK Investigational Site - Stockbridge
- GSK Investigational Site - Woodstock
Pennsylvania
- GSK Investigational Site - Carnegie
- GSK Investigational Site - Erie
- GSK Investigational Site - Erie
Kentucky
- GSK Investigational Site - Lexington
- GSK Investigational Site - Nicholasville
Arizona
- GSK Investigational Site - Chandler
Colorado
- GSK Investigational Site - Longmont
Kansas
- GSK Investigational Site - Wichita
Maryland
- GSK Investigational Site - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,013 participants |
| Start Date | 2010-08-19 |
| Est. Completion | 2011-07-29 |
| Phase | Phase 2 |
What the finished NCT01165242 record still lists
NCT01165242 is an interventional study that assigns participants to a tested intervention. Its 1,013 participants enrollment target places it among the larger protocols in the corpus, above the 379-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (167% higher).
The record links to 1 condition, with Infections, Meningococcal appearing as the primary indexed condition, and to 2 interventions - of which Meningococcal vaccine GSK 134612 is the first listed.
NCT01165242 names 20 study sites across 12 states, led by California, Georgia, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01165242 about?
NCT01165242 is a clinical study titled "Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults". The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® in subjects 10 through 25 years of age. In addition, this study will compare the immunogenicity of two lots of GSK 134612 vaccine.
What is the current status of trial NCT01165242?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,013 participants. The study started on 2010-08-19. Estimated completion is 2011-07-29.
What conditions does trial NCT01165242 study?
This clinical trial studies the following conditions: Infections, Meningococcal.
What interventions are being tested in trial NCT01165242?
The interventions under investigation include: Meningococcal vaccine GSK 134612 (BIOLOGICAL), Menactra® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01165242?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01165242 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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