NCT00956449

Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) [Ph.Eur], Formulation 2009-2010, When Administered to Non-Elderly Adult and Elderly Subjects

A Phase II, Single Center, Uncontrolled, Open-Label Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated Influenza Vaccine [Ph.Eur], Formulation 2009/2010, When Administered to Non-Elderly Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Conditions

• Influenza
• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Seasonal Influenza Vaccine	1 dose of Influenza Vaccine Surface Antigen, Inactivated

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-08-11
• Last updated: 2017-03-28

Locations

1 site across 1 country: United Kingdom