NCT00661557

Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects

Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 Administered in Healthy Subjects Either Previously Primed With Mencevax™ ACWY or naïve to Meningococcal Vaccination.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 34 Years
• Healthy volunteers: Accepted

Summary

In this study, subjects who were vaccinated with a meningococcal polysaccharide vaccine in a previous study (whose objectives \& outcome measures are presented in a separate protocol posting with NCT number = 00227422) will be vaccinated with a new vaccine using conjugation technology. These subjects will be compared to subjects vaccinated with the new vaccine, but who were not previously vaccinated with a meningococcal polysaccharide vaccine.

Detailed description

GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in toddlers, children aged 3-5 years, and adolescents/young adults. Repeated vaccinations with unconjugated meningococcal polysaccharide vaccine has shown to induce hyporesponsiveness to re-vaccination, this for serogroup C, and a recent publication suggest the same may be true for other serogroups. This study will evaluate GSK Biologicals' candidate vaccine's ability to induce satisfactory immune response for the serogroups it contains across subjects 4.5 through 34 years of age who previously received a tetravalent meningococcal polysaccharide vaccine when aged 2-30 years. A non-randomised age-strata matched group of subjects, who have not previously received (or not received within the preceding 10 years) any meningococcal vaccine, will also be administered the GSK134612 vaccine for comparison.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612 (Nimenrix)	one dose, as intramuscular injection

Timeline

• Start date: 2008-05-19
• Primary completion: 2008-12-19
• Completion: 2008-12-19
• First posted: 2008-04-18
• Last updated: 2018-12-28
• Results posted: 2018-12-28

Locations

1 site across 1 country: Lebanon