Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
Phase 2
Withdrawn
- Conditions
- Influenza
- Registration Number
- NCT00342940
- Lead Sponsor
- Novartis
- Brief Summary
The present study aims to evaluate safety and immunogenicity of one dose of a commercially available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, in non-elderly adult and elderly subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Male and female subjects 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
- known or suspected (or high risk of developing) impairment/alteration of immune function
- within the past 7 days any acute disease or infections requiring systemic antibiotic or antiviral therapy
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
- Secondary Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Chiltern International Limited , Chiltern Place, Upton Road
🇬🇧Slough, United Kingdom