Back to resultsSafety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
Primary Purpose
Influenza
Status
Withdrawn
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
influenza surface antigen inactivated vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, influenza vaccine, flu, vaccination, immunogenicity
Eligibility 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
Sites / Locations
- Chiltern International Limited , Chiltern Place, Upton Road
Outcomes
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).
Full Information
NCT ID
NCT00342940
First Posted
June 20, 2006
Last Updated
April 19, 2017
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00342940
Brief Title
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of Vaccine Supplies
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, influenza vaccine, flu, vaccination, immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
influenza surface antigen inactivated vaccine
Primary Outcome Measure Information:
Title
CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
Secondary Outcome Measure Information:
Title
Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
Title
Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
Title
Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines Drug Information Services
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Chiltern International Limited , Chiltern Place, Upton Road
City
Slough
ZIP/Postal Code
SL1 2AD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
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