Status:
COMPLETED
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over
Eligibility Criteria
Inclusion
- 18 years of age or older
Exclusion
- 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 and bleeding diathesis or conditions associated with prolonged bleeding time
- 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 (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
- fever within the past 3 days
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- within the past 12 months have received more than one injection of influenza vaccine
- 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)
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00329966
Start Date
June 1 2006
Last Update
September 14 2006
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37
Lanciano, Lanciano, Italy
2
Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini
Chieti, Italy, 66100