Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009

Tracking Information
First Submitted Date ICMJE	September 8, 2008
First Posted Date ICMJE	September 9, 2008
Last Update Posted Date	December 1, 2016
Study Start Date ICMJE	June 2008
Actual Primary Completion Date	July 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 8, 2008)	Evaluation of antibody response to each influenza vaccine antigen, as measured by Single Radial Hemolysis (SRH) test on Day 0 and on Day 21 [ Time Frame: 21 days (-1/+5) ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00748813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 8, 2008)	Evaluation of safety [ Time Frame: 21 days (-1/+5) ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine Using the Strain Composition 2008/2009
Official Title ICMJE	A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009, When Administered to Non-Elderly Adult and Elderly Sub
Brief Summary	Annual trial for registration influenza vaccine with the strain composition for season 2008/2009
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Seasonal Influenza
Intervention ICMJE	Biological: Influenza Vaccine, Formulation 2008-2009; 1 dose of Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2008-2009
Study Arms	1; Intervention: Biological: Influenza Vaccine, Formulation 2008-2009
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 8, 2008)	133
Original Actual Enrollment ICMJE	Same as current
Actual Study Completion Date	July 2008
Actual Primary Completion Date	July 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Subjects eligible for enrollment into this study are male and female adults who are: ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry able to comply with all study requirements in 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; Advanced congestive heart failure; Chronic obstructive pulmonary disease (COPD); Autoimmune disease (including rheumatoid arthritis); Acute or progressive hepatic disease; Acute or progressive renal disease; Severe neurological or psychiatric disorder; 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;; Women who are pregnant, or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days);; 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 infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days; 1 - They have experienced an acute exacerbation of a COPD within the past 14 days
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Italy
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00748813
Other Study ID Numbers ICMJE	V71P7S; 2008-001079-31
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ICMJE	Novartis Vaccines
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account	Novartis
Verification Date	December 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP