A Phase III, Multicenter, Uncontrolled, Open-Label Study to Demonstrate Safety and Immunogenicity of a Commercially Available Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 When Administered to Non-Elderly Adult and Elderly Subjects

Novartis2 sites in 1 country125 target enrollmentJuly 2006

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Novartis
Enrollment: 125
Locations: 2
Primary Endpoint: antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Due to antigenic changes of influenza viruses, the virus strains used in influenza vaccines are adjusted every year according to WHO (World Health Organization) and CHMP (Committee for Medicinal Products for Human Use) recommendations. Immunogenicity and tolerability of the newly composed vaccines are subject for evaluation in a yearly clinical trial in non-elderly and elderly subjects (CPMP/BWP/214/96).

Registry

clinicaltrials.gov

Start Date

July 2006

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Healthy adults aged \>18 years

Exclusion Criteria

•serious chronic diseases or significant acute infections requiring systemic antibiotic treatment
•history of any anaphylaxis, serious vaccine reactions
•hypersensitivity against vaccine components
•history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
•known or suspected impairment/alteration of immune function
•more than one injection of influenza vaccine received or laboratory confirmed influenza disease
•within last 6 months: influenza vaccination received