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NCT00518726 Clinical Trial

Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects

Influenza Clinical Trial

Official title:
A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00518726
Other study ID # V71P5S
Secondary ID 2007-000963-28
Status Completed
Phase Phase 2
First received August 20, 2007
Last updated November 30, 2016
Start date June 2007
Est. completion date July 2007

Study information
Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Italy: Ministero Della Salute, EMEA
Study type Interventional

Clinical Trial Summary

To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged > 18 years

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- > 18 years of age or older

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 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 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, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Surface Antigen, Inactivated, Adjuvanted, Influenza Vaccine, Formulation 2007-2008
seasonal influenza vaccine 15ug

Locations
Country Name City State
Italy Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena Siena
Italy Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio Via dei Vestini Chieti
Italy Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale Via S. Spaventa, 37, Lanciano Chieti

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects
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