- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00342940
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
April 19, 2017 updated by: Novartis
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Slough, United Kingdom, SL1 2AD
- Chiltern International Limited , Chiltern Place, Upton Road
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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CHMP criteria for evaluation of flu vaccines e.g Seroprotection, GMR's and Seroconversion rate at day 21 following vaccination
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Secondary Outcome Measures
Outcome Measure |
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Number and percentage of subjects with at least one local reaction between Day 0 and Day 3 after vaccine injection.
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Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 3 after vaccine injection.
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Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit (Day 21, window: 20-24).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Novartis Vaccines Drug Information Services, Novartis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Study Registration Dates
First Submitted
June 20, 2006
First Submitted That Met QC Criteria
June 20, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
April 20, 2017
Last Update Submitted That Met QC Criteria
April 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V78P4S
- Eudract number:2006-000787-88
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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