Status:

COMPLETED

Safety and Immunogenicity of a Inactivated Influenza Vaccine When Administered to Non Elderly Adults and Elderly Subjects.

Lead Sponsor:

Novartis

Collaborating Sponsors:

Novartis Vaccines

Conditions:

Influenza Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purpose of this study is to evaluate safety and immunogenicity of a single intramuscular (IM) injection of a Surface Antigen, Inactivated, Influenza Vaccine, Formulation 2005-2006, when Administer...

Eligibility Criteria

Inclusion

  • subjects 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
  • 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

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00316615

Start Date

June 1 2005

Last Update

September 14 2006

Active Locations (2)

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Page 1 of 1 (2 locations)

1

G. D'Annunzio University

Chieti, Italy, 66100

2

Office of Hygiene and Public Health, ASL Lanciano

Lanciano, Italy