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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014