NCT01152814

Study to Evaluate Safety and Immunogenicity of Sub-unit Adjuvanted Influenza Vaccine Administered to Elderly Subjects, Formulation 2010-2011

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2010-2011, When Administered to Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of a sub-unit, adjuvanted influenza vaccine administered to elderly subjects

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal flu vaccine	This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2010-06-29
• Last updated: 2016-01-27
• Results posted: 2016-01-27

Locations

6 sites across 1 country: Italy