NCT01161264

Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, When Administered to Adult and Elderly Subjects

A Phase III, Multicenter, Uncontrolled, Open Label Study to Evaluate Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011, 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

Influenza poses a significant threat to individual and public health, and influenza vaccination with a trivalent inactivated influenza vaccine is widely recommended to children, adults at risks and elderly. Due to antigenic changes of influenza viruses, the virus strains used in interpandemic influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Following a change in the vaccine antigen composition recommendation from the previous season, immunogenicity and tolerability of the newly composed vaccines are subject of evaluation in an annual clinical trial in non-elderly adult and elderly subjects according to the guidelines set by EMEA (CPMP/BWP/214/96).

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011	Single 0.5 mL dose administered into the deltoid muscle of (preferably) the non-dominant arm on Day 1.

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-07-13
• Last updated: 2021-03-10

Locations

1 site across 1 country: Germany