Safety and Immunogenicity of Preservative Free Inactivated Split Influenza Vaccine, Using the Strain Composition 2006/2007 in Non-Elderly Adult and Elderly Subjects

Novartis

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: preservative free inactivated split influenza vaccine using the strain composition 2006/2007

Study type

Interventional

Funder types

Industry

Identifiers

NCT00354016

EudraCT number 2006-000438-11

V44P10S

Details and patient eligibility

About

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).

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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