NCT00955682

Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612

Persistence of Antibodies After GSK Biologicals' Meningococcal Vaccine GSK134612 in Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 23 Months
• Healthy volunteers: Accepted

Summary

Subjects were previously vaccinated at 12 to 23 months of age. This extension study starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Detailed description

This study will assess the long-term protection offered by the new meningococcal vaccine GSK 134612 compared to Meningitec™ up to 4 years after vaccination of toddlers. Subjects were previously vaccinated at 12 to 23 months of age with GSK Biologicals' meningococcal vaccine GSK 134612 or Meningitec™. All subjects received at least one dose of Priorix-Tetra™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension study. No new subjects will be enrolled. The subjects will have a blood sample taken at 24, 36 and 48 months after primary vaccination. At Year 4 subjects will be boosted with the same meningococcal vaccine as given in the primary study, i.e. either the new meningococcal vaccine GSK 134612 or Meningitec™. Blood samples will be taken 1 and 12 months after the booster vaccination.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal vaccine GSK134612	One intramuscular dose (Booster)
BIOLOGICAL	Meningitec™	One intramuscular dose (Booster)

Timeline

• Start date: 2009-08-25
• Primary completion: 2009-12-16
• Completion: 2012-09-10
• First posted: 2009-08-10
• Last updated: 2021-02-26
• Results posted: 2019-08-06

Locations

14 sites across 1 country: Finland