NCT01266993

Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children

Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 271 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®. This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)

Detailed description

Subjects were previously vaccinated at 2 to 10 years of age with GSK134612 or with Menjugate®. The persistence phase starts 32 months after the primary vaccination and blood samples will be taken at 32, 44, 56 and 68 months after primary vaccination. All subjects will receive a booster dose of GSK134612 at 68 months after primary vaccination and a blood sample will be taken 1 month after administration of the booster dose.

Conditions

• Infections, Meningococcal
• Meningococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Nimenrix (GSK134612 vaccine)	Intramuscular, 1 dose
BIOLOGICAL	Menjugate	Intramuscular, 1 dose

Timeline

• Start date: 2011-01-03
• Primary completion: 2014-03-31
• Completion: 2014-05-17
• First posted: 2010-12-24
• Last updated: 2020-11-23
• Results posted: 2019-01-31

Locations

24 sites across 2 countries: France, Germany