Influenza Clinical Trial
Official title:
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted Influenza Vaccine, Formulation 2007-2008, When Administered to Elderly Subjects
Verified date | January 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministero Della Salute, EMEA |
Study type | Interventional |
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over
Status | Completed |
Enrollment | 56 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 65 years of age or older Exclusion Criteria: - any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or insulin-dependent diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time - hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin or any other component of the vaccine - history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine - known or suspected (or high risk of developing) impairment/alteration of immune function - any acute disease or infections requiring systemic antibiotic or antiviral therapy within the past 7 days - fever within the past 3 days |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Dipartimento di Medicina e Scienze dell'Invecchiamento | Chieti | |
Italy | Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto, Via S. Spaventa, 37 | Lanciano |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Antibody response to each influenza vaccine antigen as measured by Single Radial Hemolysis in elderly subjects (=65y) in compliance with the requirements of the current EU recommendations for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96) | The measures of immunogenicity for each antigen are: the geometric mean area (GMA) on Day 0 and Day 21 the Day 21/Day 0 geometric mean area ratio (GMR) the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 the percentage of subjects achieving an SRH area = 25 mm2 on Day 0 and Day 21 Seroconversion is defined as negative prevaccination serum/postvaccination serum area = 25 mm2. Significant increase in antibody titer is defined as at least a 50% increase in area. |
21 days post-vaccination | No |
Secondary | To evaluate the safety of the administration of a single intramuscular (IM) injection of FLUAD® vaccine (formulation 2007/2008) in elderly subjects (= 65 years). | Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). |
3 days, respectively 21 days post-vaccination | Yes |
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