Back to resultsYearly Strain Variation Study, 2009/2010
Primary Purpose
Influenza, Seasonal Influenza
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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
Sites / Locations
- Medical University of Vienna, Department of Clinical Pharmacology
Outcomes
Primary Outcome Measures
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00943657
Brief Title
Yearly Strain Variation Study, 2009/2010
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ology Bioservices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Seasonal Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Preflucel [Trivalent seasonal influenza vaccine (split virus, Vero cell-derived)]
Other Intervention Name(s)
Preflucel
Intervention Description
Single intramuscular injection of vaccine
Primary Outcome Measure Information:
Title
Number of subjects demonstrating seroconversion to each of the three antigens contained in the vaccine 21 days after vaccination
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Yearly Strain Variation Study, 2009/2010
We'll reach out to this number within 24 hrs