Clinical trial NCT00464672: Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza, Egg-Derived, Healthy Children, Healthy Adolescents, Healthy Adults, Safety, Immunogenicity, Trivalent, Inactivated, Vaccination
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2007-04-24
Enrollment: 1893
Sex: ALL
Minimum age (years): 3
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety,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


Eligibility criteria: 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);

Primary outcomes:
measure: Percentage of Subjects With Seroprotection, in Healthy Adults 18 to 64 Years of Age
timeFrame: 21 days after vaccination
measure: Percentage of Subjects Achieving a Seroconversion Rate, in Adults 18 to 64 Years of Age
timeFrame: 21 days after vaccination
Secondary outcomes:
measure: Number of Subjects Reporting Solicited Local and Systemic Symptoms in Adults 18 to 64 Years of Age
timeFrame: 7 days after vaccination
measure: Percentage of Subjects With Seroprotection, in Healthy Children/Adolescents 9 to 17 Years of Age
timeFrame: 21 days after vaccination
measure: Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children/Adolescents 9 to 17 Years of Age
timeFrame: 21 days after vaccination
measure: Geometric Mean Titers (GMTs), in Healthy Children/Adolescents 9 to 17 Years of Age
timeFrame: 21 days after vaccination
measure: Number of Subjects Reporting Solicited Local and Systemic Symptoms in Children/Adolescents 9 to 17 Years of Age
timeFrame: 7 days after vaccination
measure: Percentage of Subjects With Seroprotection, in Healthy Children 3 to 8 Years of Age
timeFrame: 50 days after last vaccination
measure: Percentage of Subjects Achieving Seroconversion Rate, in Healthy Children 3 to 8 Years of Age
timeFrame: 50 days after last vaccination
measure: Geometric Mean Titers (GMTs), in Healthy Children 3 to 8 Years of Age
timeFrame: 50 days after last vaccination
measure: Number or Subjects Reporting Solicited Local and Systemic Symptoms, in Healthy Children 3 to 8 Years of Age.
timeFrame: 7 days after each vaccination
measure: Geometric Mean Titers (GMTs), in Healthy Adults 18 to 64 Years of Age
timeFrame: 21 days after vaccination
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Site 2: C1425AWK
city: Cordoba
country: Argentina
facility: Site 1: X5000BJH
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References:
citation: Tregnaghi MW, Stamboulian D, Vanadia PC, Tregnaghi JP, Calvari M, Fragapane E, Casula D, Pellegrini M, Groth N. Immunogenicity, safety, and tolerability of two trivalent subunit inactivated influenza vaccines: a phase III, observer-blind, randomized, controlled multicenter study. Viral Immunol. 2012 Jun;25(3):216-25. doi: 10.1089/vim.2011.0063.