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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345

NCT01702454 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2018-09-07

Study results available
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Summary

The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).

Conditions

Interventions

BIOLOGICAL

Fluarix Quadrivalent

1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-06
Primary Completion
2013-05-06
Completion
2013-06-05

Countries

  • Czechia
  • Poland
  • Spain
  • United Kingdom

Study Locations

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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 NCT01702454 on ClinicalTrials.gov