Comparison of Safety, Tolerability and Immunogenicity of Influenza Vaccines in Adults and Elderly

This study has been completed.

First Received: March 22, 2006 Last Updated: September 13, 2006 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00306527

Purpose

The purpose of the study is to evaluate safety, tolerability and immunogenicity (in a subset) following a dose of a trivalent subunit influenza vaccine produced either in mammalian cells or in embryonated hen eggs, in healthy adult and elderly subjects who received either vaccine one year before (2004) in the study V58P4.

Condition	Intervention	Phase
Influenza	Biological: Cell culture and egg derived influenza vaccines	Phase III

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity (in a Subset) Following a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects Who Received Either One or the Other Vaccine One Year Before.

Further study details as provided by Novartis:

Primary Outcome Measures:

seroprotection, GMTs, GMRs and seroconversion rate approximately three weeks after vaccination.
Solicited local and systemic reactions for seven days after vaccination, and other adverse events for approximately three weeks after vaccination.

Secondary Outcome Measures:

Safety approximately six months after vaccination.

Estimated Enrollment:	2654
Study Start Date:	September 2005

Eligibility

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

Criteria

Inclusion Criteria:

healthy subjects who participated in Chiron Vaccines trial V58P4

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
within the past 4 weeks they have received: another vaccine; any investigational agent
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: NCT00306527

Locations

Poland

Krakow, Poland

Kielce, Poland

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines Drug Information - Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	V58P4E1, EUDRACT: 2005-001902-26
Study First Received:	March 22, 2006
Last Updated:	September 13, 2006
ClinicalTrials.gov Identifier:	NCT00306527 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by Novartis:

Influenza
adult/elderly
flu cell culture
vaccine

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
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