Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010
Primary Purpose
Seasonal Influenza
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
inactivated split influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza focused on measuring influenza vaccine, vaccine
Eligibility Criteria
Inclusion Criteria:
Subjects eligible for enrollment into this study are male and female adults who are
- ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- Able to comply with all study requirements
In good health as determined by:
- Medical history;
- Physical examination;
- Clinical judgment of the investigator. Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.
Exclusion Criteria:
Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
- Cancer, except for localized skin cancer;
- Advanced congestive heart failure;
- Chronic obstructive pulmonary disease (COPD);
- Autoimmune disease (including rheumatoid arthritis);
- Acute or progressive hepatic disease;
- Acute or progressive renal disease;
- Severe neurological or psychiatric disorder;
- Severe Asthma.
- History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:
- Receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
- Receipt of immunostimulants;
- Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study.
- Suspected or known HIV infection or HIV-related disease.
- Known or suspected history of drug or alcohol abuse.
- They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
- Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). Female who pregnant of nursing (breastfeeding) mothers of females of childbearing age who do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (oral, injection, transdermal patch, implant, cervical ring), barrier (condom or diaphragm), intrauterine device (IUD) or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry.
- Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months.
Within the past 4 weeks they have received:
- Another vaccine;
- Any investigational agent.
- Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
- They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days.
- Simultaneous participation in another clinical study.
- Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
- Severely obese with Body Mass Index (BMI) > 35.
- Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
Sites / Locations
- Site 2
- Site 1
- Site 3
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Evaluation of safety of inactivated split influenza vaccine
Secondary Outcome Measures
Full Information
NCT ID
NCT00945841
First Posted
July 22, 2009
Last Updated
April 5, 2017
Sponsor
Novartis
Collaborators
Novartis Vaccines
1. Study Identification
Unique Protocol Identification Number
NCT00945841
Brief Title
Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010
Official Title
A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Preservative Free, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010 When Administered to Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
This study is an annual trial for registration of inactivated split influenza vaccine with strain composition for season 2009/2010.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza
Keywords
influenza vaccine, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
inactivated split influenza vaccine
Intervention Description
1 dose of inactivated split influenza vaccine, using the strain composition 2009/2010
Primary Outcome Measure Information:
Title
Evaluation of antibody response to each influenza vaccine antigen, as measured by haemagglutination inhibition (HI) test on Day 0 and on Day 21
Time Frame
21 days (-1/+7)
Title
Evaluation of safety of inactivated split influenza vaccine
Time Frame
21 days (-1/+7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects eligible for enrollment into this study are male and female adults who are
≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
Able to comply with all study requirements
In good health as determined by:
Medical history;
Physical examination;
Clinical judgment of the investigator. Informed consent must be obtained for all the subjects before enrollment into the study after the nature of the study has been explained.
Exclusion Criteria:
Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
They have any serious chronic or acute disease (in the judgment of the investigator) including but not limited to:
Cancer, except for localized skin cancer;
Advanced congestive heart failure;
Chronic obstructive pulmonary disease (COPD);
Autoimmune disease (including rheumatoid arthritis);
Acute or progressive hepatic disease;
Acute or progressive renal disease;
Severe neurological or psychiatric disorder;
Severe Asthma.
History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:
Receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study;
Receipt of immunostimulants;
Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study.
Suspected or known HIV infection or HIV-related disease.
Known or suspected history of drug or alcohol abuse.
They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days). Female who pregnant of nursing (breastfeeding) mothers of females of childbearing age who do not plan to use acceptable birth control measures, for the duration of the study. Adequate contraception is defined as hormonal (oral, injection, transdermal patch, implant, cervical ring), barrier (condom or diaphragm), intrauterine device (IUD) or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject's study entry.
Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months.
Within the past 4 weeks they have received:
Another vaccine;
Any investigational agent.
Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days.
Simultaneous participation in another clinical study.
Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
Severely obese with Body Mass Index (BMI) > 35.
Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
Facility Name
Site 2
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Site 1
City
Herborn
ZIP/Postal Code
35745
Country
Germany
Facility Name
Site 3
City
Marburg
ZIP/Postal Code
35033
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity, Inactivated Split Influenza Vaccine, Using the Strain Composition 2009/2010
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