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Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children

NCT01196988 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3027

Last updated 2018-09-21

Study results available
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Summary

This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.

Conditions

Interventions

BIOLOGICAL

Influenza vaccine GSK2321138A

intramuscular injections

BIOLOGICAL

FluarixTM

intramuscular injections

BIOLOGICAL

Influenza vaccine GSK2604409A

intramuscular injections

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-04
Primary Completion
2011-06-15
Completion
2011-06-15

Countries

  • United States
  • Czechia
  • France
  • Germany
  • Philippines

Study Locations

More Related Trials

Entities

Diseases
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 NCT01196988 on ClinicalTrials.gov