Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00734734
First received: August 13, 2008
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

Trial for annual approval of interpandemic influenza vaccines


Condition Intervention Phase
Interpandemic Influenza
Biological: Seasonal Influenza Vaccine
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 2008-2009, When Administered to Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluation of immunogenicity of the NH 2008/09 influenza vaccine formulation, by means of Single Radial Hemolysis assay, at day 0 and day 21 following vaccination [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of clinical tolerability and safety of the influenza vaccine [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: June 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Seasonal Influenza Vaccine
1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation

  Eligibility

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

Inclusion Criteria:

  • 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 as determined by: medical history; physical examination; clinical judgment of the investigator.

Exclusion Criteria:

  • They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:

Cancer, except for localized skin cancer; b. Advanced congestive heart failure; c. Chronic obstructive pulmonary disease (COPD); d. Autoimmune disease (including rheumatoid arthritis);e. Acute or progressive hepatic disease; Acute or progressive renal disease; g. Severe neurological or psychiatric disorder; h. Severe asthma.

  • They have 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);
  • They have a known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting, for example, from:

receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; - receipt of immunostimulants; - receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study; suspected or known HIV infection or HIV-related disease;

  • They have a known or suspected history of drug or alcohol abuse;
  • They have a bleeding diathesis or condition 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; received influenza vaccine;

  • Within the past 4 weeks they have received:

another vaccine; any investigational agent;

  • They have any acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days;
  • They have experienced an acute exacerbation of a COPD within the past 14 days;
  • They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days;
  • They are taking part in another clinical study;
  • They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
  • They are severely obese with Body Mass Index (BMI) > 35
  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: NCT00734734

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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00734734     History of Changes
Other Study ID Numbers: V70P7S, 2008-001047-19
Study First Received: August 13, 2008
Last Updated: January 24, 2012
Health Authority: Italy: Ministero della Salute, EMEA

Keywords provided by Novartis:
Prophylaxis of Influenza
Influenza Vaccines
MF59C.1

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