Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects
Phase 2
Completed
- Conditions
- Pandemic Influenza Disease
- Registration Number
- NCT00311480
- Lead Sponsor
- Novartis
- Brief Summary
The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 520
Inclusion Criteria
- Male and female volunteers 18 years of age or older
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Exclusion Criteria
- any auto-immune disease or other serious acute, chronic or progressive disease
- 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.
- within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination
- Secondary Outcome Measures
Name Time Method Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.
Trial Locations
- Locations (4)
G. D'Annunzio University
🇮🇹Chieti, Italy
University Hospital of Siena
🇮🇹Siena, Italy
Department of Health Sciences
🇮🇹Genoa, Italy
ASL Lanciano-Vasto
🇮🇹Lanciano, Italy