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

This study has been completed.

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00354016

Purpose

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).

Condition	Intervention	Phase
Influenza	Biological: preservative free inactivated split influenza vaccine using the strain composition 2006/2007	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

antibody titers to each influenza strain measured by hemagglutination inhibition (HI) test on Day 0 and on Day 21

Secondary Outcome Measures:

safety of a single IM dose of the split influenza vaccine using solicited local and systemic reactions and adverse event reporting

Estimated Enrollment:	125
Study Start Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354016

Locations

Germany
Werksarztzentrum Herborn, Westerwaldstr 36,
Herborn, Germany, 35745
Betriebsarztlicher Dienst, Universitat Marburg, Robert-Koch-Str, 5,
Marburg, Germany, 35037

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

Study ID Numbers:	V44P10S, EudraCT number 2006-000438-11
Study First Received:	July 18, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00354016
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:

influenza
vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 14, 2009