NCT00748150

Safety and Immunogenicity of Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Subjects

A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Annual trial for registration influenza vaccine with the strain composition for season 2008/2009

Detailed description

At enrolment, subjects were stratified into two age strata (18 to 60 years, over 60 years). Total duration of the study is three weeks. Vaccinations were to be administered on day 1. Blood samples were collected at day 1 (baseline, before the vaccination) and at day 22 (three weeks after the vaccination). Sera were tested by Hemagglutination Inhibition (HI) assay. Safety was assessed until 3 weeks after the vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009	1 dose, 0.5 mL of Flu Vaccine Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2008-2009

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-09-08
• Last updated: 2012-01-05

Locations

1 site across 1 country: United Kingdom