NCT01651104

Safety and Immunogenicity of a Trivalent Influenza Vaccine When Administered to Elderly Subjects

A Phase 2, Open Label, Uncontrolled, Multicenter Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine (Fluad®), Formulation 2012/2013, When Administered to Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety of a single intramuscular (IM) injection of trivalent adjuvanted influenza study vaccine, formulation 2012/2013, in elderly subjects and the antibody response to each influenza vaccine antigen, as measured by single radial hemolysis (SRH) and hemagglutination inhibition (HI) at approximately 21 days postimmunization in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)	A single 0.5 mL dose of study 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: 2012-07-26
• Last updated: 2014-04-21
• Results posted: 2014-01-27

Locations

1 site across 1 country: Belgium