Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00718666 · ClinicalTrials.gov registry record · Phase 2
The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers
A Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 387
- Enrollment target
- 14
- Study locations
NCT00718666: Completed Phase 2 study of Infections, Meningococcal, sponsored by GlaxoSmithKline.
NCT00718666 is a Phase 2 study of Infections, Meningococcal that has completed, run by GlaxoSmithKline. The registered enrollment target is 387 participants, below the 469-participant average among 7 other Infections, Meningococcal trials with a reported enrollment target (17% lower). The trial reports 14 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00718666, a Phase 2 study of Infections, Meningococcal, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 387 participants
- Enrollment target
- 14
- Study locations
Study Summary
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number =00471081) will be evaluated. The safety and immune response of a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination will also be evaluated. In addition, the immune response to a dose of vaccine GSK134612 administered to age-matched controls not previously given a meningococcal vaccine will be evaluated. This protocol posting has been updated further to protocol amendment 2, dated 28 october 2010. The sections impacted are summary, study design, outcome measures, intervention, and eligibility criteria.
Primary Outcome
hSBA antibody titers were assessed for the MenA, MenC, MenW-135, and MenY serogroups respectively. The antibody cut-off value assessed was greater than or equal to ( ≥) 1:8.
Conditions Studied
Interventions
- BIOLOGICAL Meningococcal vaccine GSK134612
Study Locations (14)
California
- GSK Investigational Site - Antioch
- GSK Investigational Site - Fremont
- GSK Investigational Site - Hayward
- 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
Ohio
- GSK Investigational Site - Canton
Texas
- GSK Investigational Site - Amarillo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2008-10-20 |
| Est. Completion | 2014-03-28 |
| Phase | Phase 2 |
What the finished NCT00718666 record still lists
NCT00718666 is an interventional study that assigns participants to a tested intervention. The registered 387 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 (17% 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.
NCT00718666 lists 14 locations in 5 states (California, Colorado, Arkansas).
Frequently Asked Questions
What is clinical trial NCT00718666 about?
NCT00718666 is a clinical study titled "The Long-term Antibody Persistence of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Toddlers". In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting wi...
What is the current status of trial NCT00718666?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 387 participants. The study started on 2008-10-20. Estimated completion is 2014-03-28.
What conditions does trial NCT00718666 study?
This clinical trial studies the following conditions: Infections, Meningococcal.
What interventions are being tested in trial NCT00718666?
The interventions under investigation include: Meningococcal vaccine GSK134612 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00718666?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00718666 being conducted?
This trial has 14 study locations across Arkansas, California, Colorado, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Infections, Meningococcal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.
COMPLETED · Phase 2
-
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults
COMPLETED · Phase 2
-
Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects
COMPLETED · Phase 3
-
Safety of 4CMenB Exposure During Pregnancy
COMPLETED
-
Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Infant Study
COMPLETED
-
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03761108 · 387 participants · Phase 1
Phase 1/2 Study of Linvoseltamab in Adult Patients With Relapsed or Refractory Multiple Myeloma
- NCT05572632 · 387 participants · NA
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
- NCT06917079 · 387 participants · Phase 1
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
- NCT04092010 · 388 participants · NA
Improving Preschool Outcomes by Addressing Maternal Depression in Head Start
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI