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Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

NCT01144663 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2095

Last updated 2020-12-31

Study results available
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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.

Conditions

  • Infections, Meningococcal
  • Meningococcal Vaccines

Interventions

BIOLOGICAL

Nimenrix™

4- or 3-dose intramuscular injection

BIOLOGICAL

Menjugate®

3-dose intramuscular injection

BIOLOGICAL

NeisVac-CTM

3-dose intramuscular injection

BIOLOGICAL

Infanrix™ hexa

4-dose intramuscular injection

BIOLOGICAL

Synflorix™

4-dose intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-01
Primary Completion
2012-06-22
Completion
2013-09-10

Countries

  • Estonia
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144663 on ClinicalTrials.gov