Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects

This study has been completed.

First Received: April 4, 2006 Last Updated: March 12, 2007 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00311480

Purpose

The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.

Condition	Intervention	Phase
Pandemic Influenza Disease	Biological: Influenza vaccine surface antigen adjuvanted with MF59	Phase II

MedlinePlus related topics: Bird Flu Flu

Drug Information available for: MF 59 Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects

Further study details as provided by Novartis:

Primary Outcome Measures:

CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination

Secondary Outcome Measures:

Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.

Estimated Enrollment:	520
Study Start Date:	March 2006

Eligibility

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

Criteria

Inclusion Criteria:

Male and female volunteers 18 years of age or older

Exclusion Criteria:

any auto-immune disease or other serious acute, chronic or progressive disease
hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311480

Locations

Italy
G. D'Annunzio University
Chieti, Italy, 66100
ASL Lanciano-Vasto
Lanciano, Italy, 66034
University Hospital of Siena
Siena, Italy, 53100
Department of Health Sciences
Genoa, Italy, 16129

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Drug Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi P, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS ONE. 2009;4(2):e4384. Epub 2009 Feb 6.

Study ID Numbers:	V87P1, Eudract:2005-005871-14
Study First Received:	April 4, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00311480 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Novartis:

influenza
pandemic influenza
influenza vaccine
adjuvanted influenza vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Influenza in Birds
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009