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Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00956761
First received: August 8, 2009
Last updated: August 10, 2009
Last verified: August 2009
History of Changes
  Purpose

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.


Condition Intervention Phase
Seasonal Influenza
 Biological: Seasonal Influenza Vaccine (MF59C.1)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2009-2010, When Administered to Elderly Subjects

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To evaluate the antibody response to each flu vaccine antigen, as measured by SRH at 21 days post-immunization in elderly subjects in compliance with the requirements of the EU recommendations for clin. trials related to yearly licensing of flu vaccines [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety of a IM injection of an MF59 -adjuvanted seasonal flu vaccine in elderly subjects in compliance with the requirements of the current EU recommendations for clinical trials related to yearly licensing of influenza vaccines [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Seasonal Influenza Vaccine (MF59C.1)
1 dose of a surface antigen, inactivated, adjuvanted with MF59C.1, seasonal influenza vaccine, formulation 2009-2010

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects of 65 years of age or older
  • Mentally competent
  • Willing and able to give written informed consent prior to study entry
  • Able to comply with all the study requirements
  • In general good health

Exclusion Criteria:

  • Any serious chronic or acute disease disease
  • History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
  • A proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein, kanamycin and neomycin sulphate)
  • Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
  • Known or suspected history of drug or alcohol abuse
  • Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
  • Within the past 12 months, they have received more than one injection of influenza vaccine
  • Within the past 6 months, they have had laboratory confirmed influenza disease or received influenza vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956761

Locations
Italy
Site 1
Chieti, Italy, 66100
Site 2
Lanciano, Italy, 66034
Site 3
Pianiga, Italy, 30034
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis, Novartis Vaccines
ClinicalTrials.gov Identifier: NCT00956761     History of Changes
Other Study ID Numbers: V70_09S, 2009-010586-23
Study First Received: August 8, 2009
Last Updated: August 10, 2009
Health Authority: Italy: EMEA

Keywords provided by Novartis:
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013