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)
Verified date | November 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
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 |
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