Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

This study has been completed.

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00329966

Purpose

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over

Condition	Intervention	Phase
Influenza	Biological: Surface Antigen, Inactivated, Influenza (form.2006-07)	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination.

Secondary Outcome Measures:

Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Estimated Enrollment:	100
Study Start Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine known or suspected (or high risk of developing) impairment/alteration of
immune function within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
fever within the past 3 days
history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
within the past 12 months have received more than one injection of influenza vaccine
Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329966

Locations

Italy
Dipartimento di Medicina e Scienze dell’Invecchiamento Università G. D’AnnunzioVia dei Vestini
Chieti, Italy, 66100
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37
Lanciano, Italy

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines - Drug Information Services

Novartis Vaccines & Diagnostics

More Information

Study ID Numbers:	V71P4S, Eudract no.2006-000609-43
Study First Received:	May 23, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00329966
Health Authority:	Italy: Ministry of Health

Keywords provided by Novartis:

Influenza
adult
elderly
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 15, 2009