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
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 April 23, 2014