Back to resultsSafety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Primary Purpose
Seasonal Influenza, Vaccine
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Cell-derived influenza vaccine
Egg-derived influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Influenza focused on measuring influenza, vaccine
Eligibility Criteria
Inclusion Criteria:
- Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
- Able to comply with all study procedures and requirements.
Exclusion Criteria:
- History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
- Fatal prognosis of an underlying medical condition (<12 months life expectancy);
- History of Guillain-Barre syndrome;
- Bleeding diathesis or receiving anticoagulants of the coumarin type;
- Hospitalization or residence in a nursing care facility;
- Planned to receive seasonal influenza vaccine outside of this study;
- Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
- Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
- Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the 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;
- Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cTIV
TIV
Arm Description
Subjects received one vaccination of cell culture-derived influenza vaccine
Subjects received one vaccination of egg-derived influenza vaccine
Outcomes
Primary Outcome Measures
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.
Secondary Outcome Measures
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV
Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV
Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV
Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560066
Brief Title
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Official Title
A Phase IV, Multi-Center, Active-Controlled, Observer-Blind Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture (Optaflu®) or in Embryonated Hen Eggs (Agrippal®) in Adults and Elderly With and Without Underlying Medical Conditions, and to Evaluate the Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
5. Study Description
Brief Summary
Evaluation of the safety of Trivalent Subunit Influenza Vaccine Produced either in Mammalian Cell Culture or in embryonated Hen Eggs in subjects 18 years of age and above with and without underlying medical conditions and evaluation of the immunogenicity in a subset of subjects with underlying medical conditions, compared to an egg-based vaccine in a post marketing setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza, Vaccine
Keywords
influenza, vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1398 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cTIV
Arm Type
Experimental
Arm Description
Subjects received one vaccination of cell culture-derived influenza vaccine
Arm Title
TIV
Arm Type
Active Comparator
Arm Description
Subjects received one vaccination of egg-derived influenza vaccine
Intervention Type
Biological
Intervention Name(s)
Cell-derived influenza vaccine
Intervention Description
1 dose of 0.5 mL in the deltoid region of the non-dominant arm
Intervention Type
Biological
Intervention Name(s)
Egg-derived influenza vaccine
Intervention Description
1 dose of 0.5 mL in the deltoid region of the non-dominant arm
Primary Outcome Measure Information:
Title
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV
Description
Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.
Time Frame
From Day 1 up to and including Day 7 post-vaccination
Secondary Outcome Measure Information:
Title
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV
Description
Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).
Time Frame
From Day 1 through Day 7 post-vaccination
Title
Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV
Description
Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.
Time Frame
From Day 1 through Day 7 post-vaccination
Title
Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV
Description
Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).
Time Frame
Before vaccination (Day 1) and three weeks after vaccination (Day 22)
Title
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV
Description
Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).
Time Frame
Three weeks post-vaccination (Day 22)
Title
Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Description
Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).
Time Frame
Before vaccination (Day 1) and three weeks after vaccination (Day 22)
Title
Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV
Description
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).
Time Frame
Three weeks post-vaccination (Day 22)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
Able to comply with all study procedures and requirements.
Exclusion Criteria:
History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
Fatal prognosis of an underlying medical condition (<12 months life expectancy);
History of Guillain-Barre syndrome;
Bleeding diathesis or receiving anticoagulants of the coumarin type;
Hospitalization or residence in a nursing care facility;
Planned to receive seasonal influenza vaccine outside of this study;
Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the 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;
Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
City
Balve
Country
Germany
City
Duisberg
Country
Germany
City
Garmisch-Partenkirchen
Country
Germany
City
Hannover
Country
Germany
City
Herborn
Country
Germany
City
Illingen
Country
Germany
City
Kiel
Country
Germany
City
Laufach
Country
Germany
City
Marburg
Country
Germany
City
Midlum
Country
Germany
City
Olpe
Country
Germany
City
Potsdam
Country
Germany
City
Regensburg
Country
Germany
City
Unterschleißheim
Country
Germany
City
Wiesbaden
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
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