Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
- Conditions
- Influenza
- Interventions
- Biological: Comparator influenza vaccineBiological: Influenza virus vaccine
- Registration Number
- NCT00464672
- Lead Sponsor
- Novartis
- Brief Summary
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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1893
- Healthy subjects 3 to 64 years of age
- Receipt of other investigational products within 3 months or other vacine within 1 month;
- Allergy to eggs, egg products, or any other vaccine component;
- Laboratory confirmed influenza disease within 6 months;
- Have previously received an influenza vaccination (3 to 8 years only);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator influenza vaccine Comparator influenza vaccine - Influenza virus vaccine Influenza virus vaccine -
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age 21 days after vaccination 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%.
Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age 21 days after vaccination 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%.
- Secondary Outcome Measures
Name Time Method Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age 7 days after vaccination Solicited local and systemic reactions were assessed after vaccination in adults 18 to 64 years of age.
Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age 21 days after vaccination 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.
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age 21 days after vaccination 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.
Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age 21 days after vaccination 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.
Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age 7 days after vaccination Solicited local and systemic reactions were assessed after vaccination in children/adolescents 9 to 17 years of age.
Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age 50 days after last vaccination 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.
Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age 50 days after last vaccination 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.
Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age 50 days after last vaccination To evaluate immunogenicity measured by GMTs after two injections of the investigational influenza virus vaccine, in healthy children 3 to 8 years of age.
Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age. 7 days after each vaccination Solicited local and systemic reactions were assessed after each vaccination, in healthy children 3 to 8 years of age.
Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age 21 days after vaccination Immunogenicity measured by GMTs after one injection of the investigational influenza virus vaccine, in healthy adults 18 to 64 years of age.
Trial Locations
- Locations (2)
Site 2: C1425AWK
🇦🇷Buenos Aires, Argentina
Site 1: X5000BJH
🇦🇷Cordoba, Argentina