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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:


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 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