NCT00126984

Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine

A Phase II, Open (Partially Double-blind), Randomized, Controlled Dose-range Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Investigational Vaccination Regimens Versus MENINGITEC™ or MENCEVAX™ ACWY When Given as One Dose to Children Aged 12 to 14 Months and 3 to 5 Years Old

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 508 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 14 Months
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Conjugated meningococcal ACWY-TT (vaccine)	One intramuscular dose during the primary vaccination
BIOLOGICAL	DTPa/Hib containing vaccine	One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
BIOLOGICAL	Meningitec	One intramuscular dose during the primary vaccination study in subjects of 12-14 months of age
BIOLOGICAL	Mencevax ACWY	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)

Timeline

• Start date: 2005-07-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2005-08-05
• Last updated: 2016-10-07

Locations

42 sites across 2 countries: Austria, Germany