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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014