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An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

NCT01439360 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12046

Last updated 2018-09-26

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).

Conditions

Interventions

BIOLOGICAL

Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A

Intramuscular injection

BIOLOGICAL

Havrix Junior

Intramuscular injection administered to subjects aged 12 months or older

BIOLOGICAL

Prevenar 13

Intramuscular injection administered to subjects less than 12 months of age

BIOLOGICAL

Varivax/ProVarivax

Intramuscular injection administered to subjects more than 12 months of age

BIOLOGICAL

Varilrix

Subcutaneous injection administered to subjects more than 12 months of age

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2014-10-31
Completion
2014-12-31

Countries

  • Bangladesh
  • Belgium
  • Czechia
  • Dominican Republic
  • Honduras
  • India
  • Lebanon
  • Philippines
  • Poland
  • Spain
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01439360 on ClinicalTrials.gov