This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,893
Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
Site 2: C1425AWK
Buenos Aires, Argentina
Site 1: X5000BJH
Córdoba, Argentina
Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
To evaluate immunogenicity, measured by seroprotection (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of the investigational influenza virus vaccine, administered to healthy adults 18 to 64 years of age. The CBER Guidance states that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroprotection meet or exceed 70%.
Time frame: 21 days after vaccination
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase defined as at least a 4-fold increase). According to the CBER Guidance, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconverion/significant increase meet or exceed 40%.
Time frame: 21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
Time frame: 7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Time frame: 21 days after vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after one injection of the investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Time frame: 21 days after vaccination
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
To evaluate immunogenicity measured by GMTs after one injection of investigational influenza virus vaccine, administered to healthy children/adolescents 9 to 17 years of age.
Time frame: 21 days after vaccination
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
Time frame: 7 days after vaccination
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
To descriptively evaluate immunogenicity, measured by seroprotection rate (percentage of subjects achieving a hemagglutination inhibition \[HI\] titer ≥40) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Time frame: 50 days after last vaccination
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
Seroconversion rate is defined as percentage of subjects achieving seroconversion (defined as negative pre-vaccination serum \[HI\<10\]/ post-vaccination HI titer ≥40) or significant increase (defined as at least a 4-fold increase) after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Time frame: 50 days after last vaccination
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Time frame: 50 days after last vaccination
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
Time frame: 7 days after each vaccination
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
Time frame: 21 days after vaccination
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