- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00329966
Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2006/2007) When Administered to Subjects 18 Years of Age or Older
September 13, 2006 updated by: Novartis
A Phase II, Open Label, Uncontrolled, Multi 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
To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 18 years and over
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
100
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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Chieti, Italy, 66100
- Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D'AnnunzioVia dei Vestini
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Lanciano, Italy
- Ufficio Igiene e Sanità Pubblica di Lanciano, ASL, Via S. Spaventa, 37
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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:
- 18 years of age or older
Exclusion Criteria:
- any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time
- 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 (chronic antibiotic therapy for urinary tract prophylaxis was acceptable)
- fever within the past 3 days
- history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
- within the past 12 months have received more than one injection of influenza vaccine
- Women who are pregnant or women able to bear children but not willing to practice acceptable contraception for the duration of the trial (21 days)
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 Vaccines & Diagnostics
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
June 1, 2006
Study Registration Dates
First Submitted
May 23, 2006
First Submitted That Met QC Criteria
May 23, 2006
First Posted (Estimate)
May 25, 2006
Study Record Updates
Last Update Posted (Estimate)
September 14, 2006
Last Update Submitted That Met QC Criteria
September 13, 2006
Last Verified
September 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V71P4S
- Eudract no.2006-000609-43
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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