The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. Meningitec™ or Mencevax™ ACWY vaccine will serve as active control. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
508
One intramuscular dose during the primary vaccination
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
Percentage of meningococcal rSBA responders, in all subjects
Time frame: One month after the first vaccine dose
Meningococcal rSBA titres
Time frame: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose
Anti-meningococcal polysaccharide concentrations
Time frame: Prior to & 1 month after the 1st dose in all subjects and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose
Anti-tetanus toxoid seropositivity and antibody concentrations
Time frame: Prior to and one month after administration of the first vaccine dose, in all subjects
Meningococcal hSBA titers
Time frame: Prior to & 1 month after the 1st dose and 15 months after priming in all subjects of groups C and E and one month after administration of the Mencevax ACWY booster dose in all subjects who received the booster dose
Occurrence of local and general solicited adverse events
Time frame: During the 8-day follow-up period following the administration of each vaccine dose.
Occurrence of unsolicited adverse events
Time frame: During the 31-day follow-up period following the administration of each vaccine dose.
Occurrence of any serious adverse events
Time frame: Throughout the study
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One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (group E) and subcutaneous administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (group C, group E)
GSK Investigational Site
Guessing, Austria
GSK Investigational Site
Neufeld/Leitha, Austria
GSK Investigational Site
Salzburg, Austria
GSK Investigational Site
Villach, Austria
GSK Investigational Site
Wels, Austria
GSK Investigational Site
Bietigheim-Bissingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Bretten, Baden-Wurttemberg, Germany
GSK Investigational Site
Eppelheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Ludwigsburg, Baden-Wurttemberg, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
...and 32 more locations