Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

NCT00985790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2018-09-21

Study results available
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Summary

The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.

Conditions

Interventions

BIOLOGICAL

Influenza vaccine GSK2321138A

Intramuscular injection

BIOLOGICAL

Fluarix™

Intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-08
Primary Completion
2010-05-21
Completion
2010-05-21

Countries

  • Mexico

Study Locations

More Related Trials

Entities

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 NCT00985790 on ClinicalTrials.gov