MedTrace Logo

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

NCT00383123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3327

Last updated 2018-06-08

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Interventions

BIOLOGICAL

Fluarix™

Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.

BIOLOGICAL

Fluzone

Subjects were administered 1 or 2 doses\* intramuscularly, into the non-dominant upper arm for children \> 12 months of age, in the anterolateral thigh for children \< 12 months. \*Only those subjects between the age of 6 months and \< 9 years, who had no history of prior influenza vaccination, received 2 doses at months 0 \& 1.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-11-02
Primary Completion
2007-10-01
Completion
2007-10-19

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 NCT00383123 on ClinicalTrials.gov