NCT01640327

Safety and Immunogenicity of One Dose of Seasonal Trivalent Influenza Virus Vaccine (TIVf, Purified Surface Antigen, Inactivated, Egg Derived) in Adults Aged 18 Years and Above

A Phase 3, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Influenza Vaccine (Fluvirin®), Formulation 2012/2013, When Administered to Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This protocol was designed to evaluate the safety, clinical tolerability and immunogenicity of the Trivalent Influenza Virus Vaccine (TIVf, purified surface antigen, inactivated, egg derived), Northern Hemisphere formulation 2012/2013. The principal aim was to provide safety and immunogenicity data, in compliance to current EU Guidelines, with the intent of obtaining marketing approval of the vaccine formulation intended for use prior to the next influenza season in the Northern Hemisphere. The antibody response to each influenza vaccine antigen, was measured by hemagglutination inhibition (HI) and single radial hemolysis (SRH) at approximately 21 days postimmunization in adult and elderly subjects. The safety and immunogenicity of a single intramuscular (IM) injection of the vaccine was evaluated in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines (CPMP/BWP/214/96).

Conditions

• Human
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza virus vaccine (TIVf)	A single dose (0.5 mL) of vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-07-13
• Last updated: 2015-11-24
• Results posted: 2014-01-29

Locations

1 site across 1 country: Germany