At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture (Optaflu®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects
In Brief
A Phase 3 clinical trial evaluating Cell derived subunit trivalent nonadjuvanted vaccine for Influenza. Completed, enrolled 126 participants across 1 site.
Detailed Summary
The purpose of this study is to evaluate the safety of a single intramuscular (IM) injection of the cell derived subunit trivalent nonadjuvanted influenza vaccine in adult and elderly subjects and the antibody response to each influenza vaccine antigen, as measured by hemagglutination inhibition (HI) at approximately 21 days postimmunization in adult and elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.
Study Details
Timeline
Interventions
A single 0.5 mL dose of the cell derived subunit trivalent nonadjuvated influenza vaccine (TIVc) supplied in prefilled syringes and administered intramuscularly in the deltoid muscle (preferably) of the non dominant arm.