At a glance
ClinicalIndex Comparison Record- ✓Healthy subjects aged 3 to 64 years
- ✕Receipt of other investigational products within 3 months
- ✕Receipt of other vaccine within 1 month
- ✕Allergy to eggs, egg products, or any other vaccine component
- ✕Laboratory confirmed influenza disease within 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Influenza virus vaccine and Comparator influenza vaccine for Influenza. Completed, enrolled 1,893 participants across 2 sites.
Detailed 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Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical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.
Study Details
Timeline
Interventions
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.