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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
  Purpose

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 Intervention Phase
Influenza
 Biological: influenza surface antigen inactivated vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 125
Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342940

Locations
United Kingdom
Chiltern International Limited , Chiltern Place, Upton Road
Slough, United Kingdom, SL1 2AD
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines - Drug Information Services Novartis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00342940     History of Changes
Other Study ID Numbers: V78P4S, Eudract number:2006-000787-88
Study First Received: June 20, 2006
Last Updated: March 7, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
influenza
influenza vaccine
flu
vaccination
immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013