MedTrace Logo

Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

NCT00980005 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2116

Last updated 2018-09-21

Study results available
· View outcomes & findings →

Summary

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Conditions

Interventions

BIOLOGICAL

GSK investigational vaccine GSK1557482A

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

BIOLOGICAL

Fluzone®

One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-13
Primary Completion
2010-03-02
Completion
2010-06-17

Countries

  • United States

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 NCT00980005 on ClinicalTrials.gov