- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00943657
Yearly Strain Variation Study, 2009/2010
October 7, 2015 updated by: Ology Bioservices
An Open-Label Phase 3 Study to Assess the Immunogenicity and Safety of a Vero Cell-Derived Trivalent Seasonal Influenza Vaccine, Strain Composition 2009/2010, in an Adult and Elderly Population
The purpose of this study is to verify the immunogenicity and tolerance of a trivalent seasonal influenza vaccine with strain composition according to World Heath Organization/European Union (WHO/EU) recommendation for the 2009/2010 season for yearly licensing application.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
110
Phase
- Phase 3
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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Vienna, Austria, 1090
- Medical University of Vienna, Department of Clinical Pharmacology
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only)
- Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only)
- Subject has given written informed consent prior to study entry
- Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice
- Subject agrees to keep a daily record of symptoms for the duration of the study
- If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study
- Subject is willing and able to comply with the requirements of the protocol
Exclusion Criteria:
- Subject has a history of severe allergic reaction or anaphylaxis
- Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study
- Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating
- Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry
- Subject has received a seasonal influenza vaccine within 6 months of study entry
- Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder
- Subject has any inherited or acquired immunodeficiency
- Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs.
- Subject has a functional or surgical asplenia
- Subject has a known or suspected problem with alcohol or drug abuse
- Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie, children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study
- If female, subject is pregnant or lactating at the time of study enrollment
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 |
Time Frame |
---|---|
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination
Time Frame: 21 days
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21 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
July 21, 2009
First Submitted That Met QC Criteria
July 21, 2009
First Posted (Estimate)
July 22, 2009
Study Record Updates
Last Update Posted (Estimate)
October 9, 2015
Last Update Submitted That Met QC Criteria
October 7, 2015
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 720901
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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