CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 387 enrolled
Drug / intervention
Meningococcal vaccine GSK134612biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00718666
NCT00718666Phase 2Completed

Long Term Antibody Persistence Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Administered as 1 or 2 Doses to Healthy Toddlers at 9-12 Months of Age and as a Booster Dose at 5 Years Post-primary Vaccination

GlaxoSmithKline·interventional·Posted Jul 21, 2008·Updated Jun 26, 2019

In Brief

A Phase 2 clinical trial evaluating Meningococcal vaccine GSK134612 for Infections, Meningococcal. Completed, enrolled 387 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 21, 2008
Enrollment StartOct 20, 2008
Primary CompletionNov 13, 2013
Study CompletionMar 28, 2014
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 17.9 years ago

Interventions

Meningococcal vaccine GSK134612biological

One dose, as intramuscular injection