CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 271 enrolled
Drug / intervention
Nimenrix (GSK134612 vaccine) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01266993
NCT01266993Phase 3Completed

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

GlaxoSmithKline·interventional·Posted Dec 24, 2010·Updated Nov 23, 2020

In Brief

A Phase 3 clinical trial evaluating Nimenrix (GSK134612 vaccine) and Menjugate for Infections, Meningococcal and Meningococcal Vaccines. Completed, enrolled 271 participants across 24 sites in 2 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2010
Enrollment StartJan 3, 2011
Primary CompletionMar 31, 2014
Study CompletionMay 17, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 15.5 years ago

Interventions

Nimenrix (GSK134612 vaccine)biological

Intramuscular, 1 dose

Menjugatebiological

Intramuscular, 1 dose