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 With MF59C.1) Influenza Vaccine, Formulation 2005-2006, When Administered to Elderly Subjects.
Verified date | September 2006 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of an adjuvanted influenza vaccine in elderly subjects.
Status | Completed |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - 65 years of age or older and in good health Exclusion Criteria: - Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure. - any acute disease or infections requiring systemic antibiotic or antiviral therapy - hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin 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 within the past 7 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 | G. D'Annunzio University | Chieti | |
Italy | Office of Hygiene and Public Health, ASL Lanciano | Lanciano |
Lead Sponsor | Collaborator |
---|---|
Novartis | Novartis Vaccines |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination. | |||
Secondary | Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection. | |||
Secondary | Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection. | |||
Secondary | Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24). |
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