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

August 13, 2008
January 24, 2012
June 2008
July 2008   (final data collection date for primary outcome measure)
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 ]
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: Yes ]
Complete list of historical versions of study NCT00734734 on ClinicalTrials.gov Archive Site
Evaluation of clinical tolerability and safety of the influenza vaccine [ Time Frame: 21 days (-1 / + 5 days) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2008-2009
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

Trial for annual approval of interpandemic influenza vaccines

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Interpandemic Influenza
Biological: Seasonal Influenza Vaccine
1 single intramuscular dose of influenza vaccine, 2008/2009 NH formulation
Experimental: 1
Intervention: Biological: Seasonal Influenza Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00734734
V70P7S, 2008-001047-19
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines Novartis Vaccines
Novartis
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP