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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Novartis Vaccines
- Enrollment
- 2654
- Locations
- 5
- Primary Endpoint
- Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Percentages Of Subjects Who Achieved HI Titer ≥40 After One Vaccination of Cell Culture-derived (cTIV) or Egg-derived (TIV) Influenza Subunit Vaccines
Time Frame: Before vaccination (day 1) and three weeks after vaccination (day 22)
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.
Geometric Mean Ratio of Subjects After One Vaccination of cTIV or TIV
Time Frame: Three weeks after vaccination (day 22)
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.
Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titer After One Vaccination of cTIV or TIV
Time Frame: Three weeks after vaccination (day 22)
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.
Secondary Outcomes
- Number of Subjects Who Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination(Up to 7 days postvaccination)