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Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers

NCT01340898 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 753

Last updated 2019-08-06

Study results available
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Summary

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

Conditions

  • Meningococcal Infection

Interventions

BIOLOGICAL

Meningococcal vaccine GSK 134612

Intramuscular injection

BIOLOGICAL

SynflorixTM

Intramuscular injection

BIOLOGICAL

Infanrix-IPV/HiberixTM

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
2012-01-27
Primary Completion
2014-08-04
Completion
2015-10-19

Countries

  • Lebanon
  • Mexico

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 NCT01340898 on ClinicalTrials.gov