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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,327
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.
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.
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.
Time frame: 21 or 28 days after last vaccine dose
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.
Time frame: 21 or 28 days after last vaccine dose
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.
Time frame: Up to 6 months after vaccination
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.
Time frame: Before (PRE) and 21 or 28 days after (POST) the last vaccine dose
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.
Time frame: 21 or 28 days after last vaccine dose
Number of Subjects Reporting Solicited Local and General Symptoms
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GSK Investigational Site
Antioch, California, United States
GSK Investigational Site
Fairfield, California, United States
GSK Investigational Site
Fresno, California, United States
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Pleasanton, California, United States
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Redwood City, California, United States
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Richmond, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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San Francisco, California, United States
GSK Investigational Site
San Francisco, California, United States
...and 30 more locations
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.
Time frame: During a 4-day follow-up period after each vaccination
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.
Time frame: Within 28 days following vaccination
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.
Time frame: Up to 6 months after vaccination