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

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383123
• Other study ID #: 104858
• Status: Completed
• Phase: Phase 3
• Start date: November 2, 2006
• Est. completion date: October 19, 2007

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3327
• Est. completion date: October 19, 2007
• Est. primary completion date: October 1, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Antioch	California
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bardstown	Kentucky
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Englewood	Colorado
United States	GSK Investigational Site	Fairfield	California
United States	GSK Investigational Site	Fishkill	New York
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Hopewell Junction	New York
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Layton	Utah
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pleasanton	California
United States	GSK Investigational Site	Poughkeepsie	New York
United States	GSK Investigational Site	Redwood City	California
United States	GSK Investigational Site	Richmond	California
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rolling Hills Estates	California
United States	GSK Investigational Site	Sacramento	California
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	San Angelo	Texas
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	San Francisco	California
United States	GSK Investigational Site	Santa Clara	California
United States	GSK Investigational Site	Santa Rosa	California
United States	GSK Investigational Site	South Jordan	Utah
United States	GSK Investigational Site	Sylva	North Carolina
United States	GSK Investigational Site	Tifton	Georgia
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Vacaville	California
United States	GSK Investigational Site	Vallejo	California
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	Whitehouse Station	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies	GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.	21 or 28 days after last vaccine dose
Primary	Number of Seroconverted Subjects	Seroconverted subjects are defined as subjects with either a pre-vaccination HI 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.; Data are presented for all 3 viral strains comprised in the vaccine.	21 or 28 days after last vaccine dose
Primary	Number of Subjects Reporting Rare Serious Events	Rare serious event is defined as any untoward medical event with an occurrence rate of =1/300 that: resulted in death,; was life-threatening,; required hospitalization or prolongation of existing hospitalization,; resulted in disability/incapacity, or; was a congenital anomaly/birth defect in the offspring of a study subject.	Up to 6 months after vaccination
Secondary	Number of Seroprotected Subjects	Seroprotected subjects are defined as vaccinees with a serum HI titer = 1:40. Data are presented for all 3 viral strains comprised in the vaccine.	Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
Secondary	Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer	Initially unprotected subjects are subjects with a baseline HI titer < 1:40. Data are presented for all 3 viral strains comprised in the vaccine.	21 or 28 days after last vaccine dose
Secondary	Number of Subjects Reporting Solicited Local and General Symptoms	Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering.; Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.	During a 4-day follow-up period after each vaccination
Secondary	Number of Subjects Reporting Unsolicited Adverse Events	An Adverse Event 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.; Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.	Within 28 days following vaccination
Secondary	Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE)	SAE: any untoward medical occurrence that; resulted in death,; was life-threatening,; required hospitalization or prolongation of existing hospitalization,; resulted in disability/incapacity, or; was a congenital anomaly/birth defect in the offspring of a study subject.; Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.	Up to 6 months after vaccination

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.