Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

Influenza Clinical Trial

Official title:

Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764790
• Other study ID #: 111751
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2008
• Est. completion date: June 1, 2009

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3317
• Est. completion date: June 1, 2009
• Est. primary completion date: March 5, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 35 Months

Eligibility

Inclusion Criteria:

• A male or female child aged 6 to 35 months at the time of the first 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.

• Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or 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 criterion.

• 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 enrolment.

• History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.

• Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.

• Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
• Fluzone
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

Locations

Country	Name	City	State
Hong Kong	GSK Investigational Site	Pokfulam
Hong Kong	GSK Investigational Site	Shatin
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Mexico city
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
United States	GSK Investigational Site	Arkansas City	Kansas
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Austintown	Ohio
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Benton	Arkansas
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Boone	North Carolina
United States	GSK Investigational Site	Bossier City	Louisiana
United States	GSK Investigational Site	Bountiful	Utah
United States	GSK Investigational Site	Burke	Virginia
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Cincinnati	Ohio
United States	GSK Investigational Site	Clarksville	Tennessee
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Conway	Arkansas
United States	GSK Investigational Site	Cortland	New York
United States	GSK Investigational Site	Dayton	Ohio
United States	GSK Investigational Site	DeKalb	Illinois
United States	GSK Investigational Site	Dothan	Alabama
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fayetteville	Arkansas
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Greenville	Pennsylvania
United States	GSK Investigational Site	Gresham	Oregon
United States	GSK Investigational Site	Henderson	Nevada
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Jackson	Tennessee
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	Kingsport	Tennessee
United States	GSK Investigational Site	Latrobe	Pennsylvania
United States	GSK Investigational Site	Layton	Utah
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Murray	Utah
United States	GSK Investigational Site	Nampa	Idaho
United States	GSK Investigational Site	New Albany	Indiana
United States	GSK Investigational Site	Newton	Kansas
United States	GSK Investigational Site	Norwich	Connecticut
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Paramount	California
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Provo	Utah
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Roy	Utah
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Paul	Minnesota
United States	GSK Investigational Site	San Angelo	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	South Jordan	Utah
United States	GSK Investigational Site	Stevensville	Michigan
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	West Covina	California
United States	GSK Investigational Site	Wexford	Pennsylvania
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Hong Kong,  Mexico,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains	GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.; Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 0 (PRE), Day 28 or Day 56 (POST)
Primary	Number of Subjects Who Seroconverted	Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer = 1:40, or a pre-vaccination titer = 1:10 and a minimum 4-fold increase at post-vaccination titer.; Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 28 or Day 56
Secondary	Number of Seroprotected Subjects	A seroprotected subject is a subject with a serum anti-HA titer; = 1:40; Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 0 (PRE), Day 28 or Day 56 (POST)
Secondary	Seroconversion Factor	Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).; Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects	Day 28 or Day 56
Secondary	Number of Subjects Reporting Solicited Local Symptoms	Solicited local symptoms assessed include pain, redness and swelling.	During a 4-day follow-up period after vaccination
Secondary	Number of Subjects Reporting Solicited General Symptoms	Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.	During a 4-day follow-up period after vaccination
Secondary	Number of Subjects Reporting Unsolicited Adverse Events (AE)	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product	During a 28-day follow-up period after vaccination
Secondary	Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)	An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.; NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders	During the entire study (Day 0 until Month 6)
Secondary	Number of Subjects Reporting Rare Serious Events	Rare serious events have an occurrence rate of 1/300 (0.3%).	During the entire study (Day 0 until Month 6)

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