Back to resultsSafety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Cell culture-derived trivalent subunit influenza vaccine (cTIV)
Egg-derived trivalent subunit influenza vaccine (TIV)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring safety, immunogenicity, non-inferiority, MDCK, cell culture-derived, subunit influenza vaccine, influenza prevention
Eligibility Criteria
Inclusion Criteria:
- 18 to 60 years of age (first age group) OR over 60 years of age (second age group)
- mentally competent to understand the nature, the scope and the consequences of the study
- able and willing to give written informed consent prior to study entry
- available for all the visits scheduled in the study
- residence in the study area
in good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the investigator.
Exclusion Criteria:
- unable or unwilling to give written informed consent to participate in the study
- suffering from an acute infectious disease
any serious disease such as:
- cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
- autoimmune disease (including rheumatoid arthritis),
- advanced arteriosclerotic disease or complicated diabetes mellitus,
- chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
- acute or progressive hepatic disease,
- acute or progressive renal disease,
- congestive heart failure
- surgery planned during the study period
- bleeding diathesis
- history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
known or suspected impairment/alteration of immune function resulting from:
- receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
- 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,
- high risk for developing an immunocompromising disease within the past 6 months
- history of drug or alcohol abuse
- laboratory confirmed influenza disease in the past 6 months
- received influenza vaccine within the past 6 months
- received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
- any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
- pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
- any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
Sites / Locations
- Wojewódzki Szpital Dzieciecy
- N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o.
- Praktyka Grupowa Lekarzy POZ "Familia"
- Szpital Jana Pawła II
- Centrum Farmakologii Klinicznej
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cell culture-derived influenza vaccine (cTIV)
Egg-derived influenza virus vaccine (TIV)
Arm Description
Outcomes
Primary Outcome Measures
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
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 cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.
In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group.
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.
Secondary Outcome Measures
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00492063
Brief Title
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
Official Title
A Phase III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture and of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult and Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The present study aims to evaluate the safety and immunogenicity of the new influenza subunit vaccine produced in Madin Darby Canine Kidney (MDCK) cells in healthy adult and elderly subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
safety, immunogenicity, non-inferiority, MDCK, cell culture-derived, subunit influenza vaccine, influenza prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2654 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cell culture-derived influenza vaccine (cTIV)
Arm Type
Experimental
Arm Title
Egg-derived influenza virus vaccine (TIV)
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Cell culture-derived trivalent subunit influenza vaccine (cTIV)
Intervention Description
One vaccination (0.5 mL) of cell culture-derived influenza vaccine (cTIV) was administered in the deltoid muscle
Intervention Type
Biological
Intervention Name(s)
Egg-derived trivalent subunit influenza vaccine (TIV)
Intervention Description
One vaccination (0.5 mL) of egg-derived influenza virus vaccine (TIV) was administered in the deltoid muscle
Primary Outcome Measure Information:
Title
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
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 cTIV or TIV vaccine for each of three vaccine strains, evaluated using the hemagglutination inhibition (HI) egg-derived antigen assay.
In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the percentage of subjects achieving HI titers ≥40 is >70% in the ≥18 to ≤60 years of age group or >60% in the ≥61 years of age group.
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 Titer After One Vaccination of cTIV or TIV
Description
Seroconversion or significant in HI titer is defined as the percentage of subjects with a prevaccination HI titer <10 (negative) to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, at least a 4-fold increase in postvaccination HI titer. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), the criterion is met if the percentage of subjects achieving seroconversion/significant increase is >40% in the ≥18 to ≤60 years of age group or >30% in the ≥61 years of age group.
Time Frame
Three weeks after vaccination (day 22)
Title
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
Description
Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI Geometric Mean Titers (GMTs), three weeks after (day 22) one vaccination of cTIV or TIV. In compliance with the requirements of the EMEA recommendations (CPMP/BWP/2490/00, CPMP/BWP/214/96), this criterion is met if the GMR (day 22/day 1) in HI antibody titer is >2.5 in the ≥18 to ≤60 years of age group or >2.0 in the ≥61 years of age group.
Time Frame
Three weeks after vaccination (day 22)
Secondary Outcome Measure Information:
Title
Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Description
The solicited local and systemic reactions were collected from day 1 up to and including day 7 after vaccination for both the vaccine groups.
Time Frame
Up to 7 days postvaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 to 60 years of age (first age group) OR over 60 years of age (second age group)
mentally competent to understand the nature, the scope and the consequences of the study
able and willing to give written informed consent prior to study entry
available for all the visits scheduled in the study
residence in the study area
in good health as determined by:
medical history,
physical examination,
clinical judgment of the investigator.
Exclusion Criteria:
unable or unwilling to give written informed consent to participate in the study
suffering from an acute infectious disease
any serious disease such as:
cancer (except for benign or localized skin cancer and non metastatic prostate cancer not currently treated with chemotherapy),_
autoimmune disease (including rheumatoid arthritis),
advanced arteriosclerotic disease or complicated diabetes mellitus,
chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
acute or progressive hepatic disease,
acute or progressive renal disease,
congestive heart failure
surgery planned during the study period
bleeding diathesis
history of hypersensitivity to any component of the study medication or chemically related substances, such as allergy to eggs or egg products
known or suspected impairment/alteration of immune function resulting from:
receipt of immunosuppressive therapy (any cortical steroid or cancer chemotherapy),
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,
high risk for developing an immunocompromising disease within the past 6 months
history of drug or alcohol abuse
laboratory confirmed influenza disease in the past 6 months
received influenza vaccine within the past 6 months
received another vaccine or any investigational agent within the past 60 days, or planned vaccination within 3 weeks following the study vaccination
any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis was acceptable) or experienced fever ≥ 38°C within the past 3 days
pregnant women or women who refused to use a reliable contraceptive method throughout the study (180 days)
any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
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
Wojewódzki Szpital Dzieciecy
City
ul. Langiewicza 2
State/Province
Kielce
ZIP/Postal Code
25-381
Country
Poland
Facility Name
N ZOZ Jagiellonskie, Centrum Medyczne Sp. z o.o.
City
os. Jagiellonskie 1
State/Province
Kraków
ZIP/Postal Code
31-832
Country
Poland
Facility Name
Praktyka Grupowa Lekarzy POZ "Familia"
City
Pl. Sikorskiego 6a
State/Province
Kraków
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Szpital Jana Pawła II
City
ul. Pradnicka 80
State/Province
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Centrum Farmakologii Klinicznej
City
Krakow
ZIP/Postal Code
30-969
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19673651
Citation
Szymczakiewicz-Multanowska A, Groth N, Bugarini R, Lattanzi M, Casula D, Hilbert A, Tsai T, Podda A. Safety and immunogenicity of a novel influenza subunit vaccine produced in mammalian cell culture. J Infect Dis. 2009 Sep 15;200(6):841-8. doi: 10.1086/605505. Erratum In: J Infect Dis. 2009 Dec 1;200(11):1801-2.
Results Reference
result
Learn more about this trial
Safety and Immunogenicity of a Cell Culture-derived Influenza Vaccine in Healthy Adults and Elderly
We'll reach out to this number within 24 hrs