Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

This study is ongoing, but not recruiting participants.

First Received: November 16, 2007 Last Updated: January 7, 2010 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00560066

Purpose

Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, both compared to an egg-based vaccine in a post marketing setting.

Condition	Intervention	Phase
Seasonal Influenza Vaccine	Biological: Cell-derived influenza vaccine Biological: Egg-derived influenza vaccine	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety Study
Official Title:	A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To compare the safety of a single intramuscular (IM) dose of the cell-derived influenza subunit vaccine with that of the egg-derived influenza subunit vaccine in adult and elderly subjects with and without underlying conditions. [ Time Frame: 21 days ]

Secondary Outcome Measures:

To evaluate the immunogenicity of both vaccines for each influenza vaccine strain, as measured by hemagglutination inhibition (HI) test 21 days after vaccination in a subset of adult and elderly subjects with underlying medical conditions. [ Time Frame: 21 days ]

Enrollment:	1372
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2008

Arms	Assigned Interventions
1: Experimental	Biological: Cell-derived influenza vaccine 1 dose of 0.5 mL in the deltoid region of the non-dominant arm
2: Active Comparator	Biological: Egg-derived influenza vaccine 1 dose of 0.5 mL. IM, in the deltoid region of the non-dominant arm

Eligibility

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

Criteria

Inclusion Criteria:

subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
able to comply with all study procedures and requirements.

Exclusion Criteria:

history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component
fatal prognosis of an underlying medical condition (<12 months life expectancy)
history of Guillain-Barré syndrome
bleeding diathesis or receiving anticoagulants of the coumarin type
hospitalization or residence in a nursing care facility
plans to receive seasonal influenza vaccine outside of this study
receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study
fever (defined as axillary temperature ³38.0°C) or any acute illness within 3 days prior to study vaccination
receipt of another investigational agent within 30 days prior to enrollment
females who are pregnant or nursing (breastfeeding) mothers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560066

Locations

Germany

Duisberg, Germany

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Study ID Numbers:	V58P14, 2007-002872-32
Study First Received:	November 16, 2007
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00560066 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institute

Keywords provided by Novartis:

influenza
vaccine

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 February 08, 2010