CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,095 enrolled
Drug / intervention
Nimenrix™ +4 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/NCT01144663
NCT01144663Phase 3Completed
CompareCT.gov

Immunogenicity and Safety of GSK Biologicals' Meningococcal Vaccine (GSK 134612) When Co-administered With a Pneumococcal Conjugate Vaccine and Infanrix Hexa™ in Healthy Infants

GlaxoSmithKline·interventional·Posted Jun 15, 2010·Updated Dec 31, 2020

In Brief

A Phase 3 clinical trial evaluating Nimenrix™, Menjugate®, and 3 other interventions for Infections, Meningococcal and Meningococcal Vaccines. Completed, enrolled 2,095 participants across 44 sites in 3 countries.

Detailed Summary

The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal, Meningococcal Vaccines
CountriesEstonia, Germany, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2010
Enrollment StartJul 1, 2010
Primary CompletionJun 22, 2012
Study CompletionSep 10, 2013
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 16.0 years ago

Interventions

Nimenrix™biological

4- or 3-dose intramuscular injection

Menjugate®biological

3-dose intramuscular injection

NeisVac-CTMbiological

3-dose intramuscular injection

Infanrix™ hexabiological

4-dose intramuscular injection

Synflorix™biological

4-dose intramuscular injection