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Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older

This study has suspended participant recruitment.
(Lack of Vaccine Supplies)
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00342940
First received: June 20, 2006
Last updated: March 7, 2007
Last verified: March 2007
History of Changes

June 20, 2006
March 7, 2007
October 2006
Not Provided
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
Same as current
Complete list of historical versions of study NCT00342940 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
A Phase II, Open-Label, Uncontrolled, Single Center Study to Evaluate Safety and Immunogenicity of a Commercially Available Surface Antigen, Inactivated Influenza Vaccine, Formulation 2006-2007, When Administered to Non-Elderly Adult and Elderly Subjects

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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Influenza
Biological: influenza surface antigen inactivated vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
125
Not Provided
Not Provided

Inclusion Criteria:

  • Male and female subjects 18 years of age or older

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00342940
V78P4S, Eudract number:2006-000787-88
Not Provided
Not Provided
Novartis
Novartis Vaccines
Study Chair: Novartis Vaccines - Drug Information Services Novartis
Novartis
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP