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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00342940
Recruitment Status : Withdrawn (Lack of Vaccine Supplies)
First Posted : June 21, 2006
Last Update Posted : April 20, 2017
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by:
Novartis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Biological: influenza surface antigen inactivated vaccine Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination

Secondary Outcome Measures :
  1. Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
  2. Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
  3. Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342940


Locations
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United Kingdom
Chiltern International Limited , Chiltern Place, Upton Road
Slough, United Kingdom, SL1 2AD
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines Drug Information Services Novartis
More Information
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ClinicalTrials.gov Identifier: NCT00342940    
Other Study ID Numbers: V78P4S
Eudract number:2006-000787-88
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Keywords provided by Novartis:
influenza
influenza vaccine
flu
vaccination
immunogenicity
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases