Influenza Clinical Trial
Official title:
A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years
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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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.
Status | Completed |
Enrollment | 1893 |
Est. completion date | December 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 3 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Healthy subjects 3 to 64 years of age Exclusion Criteria: - 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); |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Argentina | Site 2: C1425AWK | Buenos Aires | |
Argentina | Site 1: X5000BJH | Cordoba |
Lead Sponsor | Collaborator |
---|---|
Novartis | Novartis Vaccines |
Argentina,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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%. | 21 days after vaccination | No |
Primary | 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%. | 21 days after vaccination | No |
Secondary | 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. | 7 days after vaccination | Yes |
Secondary | 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. | 21 days after vaccination | No |
Secondary | 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. | 21 days after vaccination | No |
Secondary | 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. | 21 days after vaccination | No |
Secondary | 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. | 7 days after vaccination | Yes |
Secondary | 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. | 50 days after last vaccination | No |
Secondary | 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. | 50 days after last vaccination | No |
Secondary | 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. | 50 days after last vaccination | No |
Secondary | 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. | 7 days after each vaccination | Yes |
Secondary | 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. | 21 days after vaccination | No |
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