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 has been completed.

First Received on November 16, 2007. Last Updated on December 13, 2011 History of Changes

Sponsor:	Novartis Vaccines
Information provided by (Responsible Party):	Novartis ( Novartis Vaccines )
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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Enrollment:	1372
Study Start Date:	November 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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

Investigators

Study Chair:

Novartis Vaccines

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00560066 History of Changes
Other Study ID Numbers:	V58P14, 2007-002872-32
Study First Received:	November 16, 2007
Last Updated:	December 13, 2011
Health Authority:	Germany: Paul-Ehrlich-Institute

Keywords provided by Novartis:

influenza
vaccine

Additional relevant MeSH terms:

Disease
Influenza, Human
Pathologic Processes
Orthomyxoviridae Infections

RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012