Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00383123

Purpose

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.

Condition	Intervention	Phase
Influenza	Biological: Fluzone Biological: Fluarix	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Single-Blind, Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix® (GSK Biologicals) Compared With Fluzone® (Aventis Pasteur/Sanofi) Administered Intramuscularly in Children (6 Months and Older)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of Rare Serious Events [ Time Frame: overall ]
Geometric Mean Titer (GMT) of Serum Haemagglutination-Inhibition (HI) Antibodies in Children Aged 6 Months to < 5 Years [ Time Frame: 21 or 28 days after last vaccine dose ] [ Designated as safety issue: No ]
Seroconversion Rate in Children Aged 6 Months to <5 Years [ Time Frame: 21 or 28 days after last vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of New Onset Chronic Illnesses and/or Serious Adverse Events [ Time Frame: During the entire study ]
Percentage, Intensity and Relationship to Vaccination of Unsolicited Symptoms [ Time Frame: During the follow-up period(s) after each vaccination ]
Percentage of Subjects With a Minimum of 4 Fold Increase in HI Titer if Baseline Titer is < 1:40 (Only for Subjects Aged 6 Months to < 5 Years) [ Time Frame: overall ] [ Designated as safety issue: No ]
Pre and Post-Vaccination Seroprotection Rate for Subjects Aged 6 Months to < 5 Years [ Time Frame: At 21 or 28 days after the last vaccine dose ] [ Designated as safety issue: No ]
Percentage, Intensity and Relationship to Vaccination of Solicited Local and General Signs and Symptoms [ Time Frame: During a 4-day follow-up period after each vaccination ]

Enrollment:	3327
Study Start Date:	October 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fluarix Group: Experimental Subjects in this group will be further stratified by 3 age groups 1:1 in 6 months to < 36 months 1:1 in 3 to < 5 years 3:1 in 5 to < 18 years	Biological: Fluarix Intramuscular injection, one or two doses
Fluzone Group: Active Comparator Subjects in this group will be further stratified by 3 age groups 1:1 in 6 months to < 36 months 1:1 in 3 to < 5 years 3:1 in 5 to < 18 years	Biological: Fluzone Intramuscular injection, one or two doses

Eligibility

Ages Eligible for Study:	6 Months to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

A male or female child age 6 months to < 18 years at the time of the vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
Written informed consent obtained from the subject's parent/guardian; assent obtained in subjects > 10 years.
Female subjects of childbearing potential must agree to take a pregnancy test.

Exclusion criteria:

Use of any investigational or non-registered product (drug or vaccine, other than the study vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion.
History of hypersensitivity to any vaccine.
History of allergy or reactions likely to be exacerbated by any component of the vaccine
Acute disease at the time of enrollment
History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
Pregnant or lactating female.
Receipt of an influenza vaccine outside of this study, during current (2006-07) flu season.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383123

Show 37 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	104858
Study First Received:	September 29, 2006
Results First Received:	October 15, 2008
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00383123 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Influenza
Fluarix

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009