Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464672
• Other study ID #: V71P5
• Secondary ID: IND: 13299
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2007
• Last updated: September 16, 2015
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Medica (ANMAT)
• Study type: Interventional

Clinical Trial 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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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.

Recruitment information / eligibility

• 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);

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza virus vaccine
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.
• Comparator influenza vaccine
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.

Locations

Country	Name	City	State
Argentina	Site 2: C1425AWK	Buenos Aires
Argentina	Site 1: X5000BJH	Cordoba

Sponsors (2)

Lead Sponsor	Collaborator
Novartis	Novartis Vaccines

Country where clinical trial is conducted

Argentina, 

Outcome

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