A Phase III, Multicenter, Uncontrolled, Open-label Study to Evaluate Safety and Immunogenicity of a Single Intramuscular Dose of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture, Using the Strain Composition 2007/2008, When Administered to Adult and Elderly Subjects
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Seasonal Influenza Vaccine
- Sponsor
- Novartis Vaccines
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Annual trial for registration of sub-unit influenza vaccine produced in mammalian cell culture, using the strain composition 2007/2008, when administered to adult and elderly subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects eligible for enrollment into this study are male and female adults who were:
- •≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
- •available for all the visits scheduled in the study and able to comply with all study requirements
- •in good health as determined by:
- •medical history
- •physical examination
- •clinical judgment of the investigator Written informed consent had to be obtained from all the subjects before enrollment in the study after the nature of the study had been explained.
Exclusion Criteria
- •Subjects were not to be enrolled into the study if at least one of the following criteria was fulfilled:
- •Any serious chronic or acute disease such as:
- •Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy
- •Congestive heart failure
- •Advanced arteriosclerotic disease
- •Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days.
- •Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below)
- •Insulin dependent diabetes mellitus
- •Acute or progressive hepatic disease
- •Acute or progressive renal disease
Outcomes
Primary Outcomes
Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Time Frame: 3 weeks postvaccination (Day 22)
Pre and postvaccination geometric mean titers against all 3 strains were assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects.
Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV)
Time Frame: 3 weeks postvaccination (Day 22)
Geometric mean ratio (GMR) of Day 22 / Day 1 geometric mean antibody titers was assessed by hemagglutination inhibition (HI)assay using egg derived antigen in adults and elderly subjects. The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (Day22 / Day1) in HI antibody titer is \>2.5 for adults and \>2.0 for elderly subjects.
Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Time Frame: 3 weeks postvaccination (Day 22)
HI titer as assessed by hemagglutination inhibition (HI) assay using egg derived antigen in adults and elderly subjects. This criterion is met according to European (CHMP) guideline if the percentages of subjects achieving HI titers ≥40 is \>70% for adults and \>60% for elderly subjects.
Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV).
Time Frame: 3 weeks postvaccination (Day 22)
Proportion of subjects with either seroconversion (antibody increase from \< 10 pre vaccination to ≥40 post vaccination) or significant increase (antibody titer of ≥10 pre vaccination and 4-fold antibody increase post vaccination). According to the CHMP criteria, the percentages of subjects achieving seroconversion or significant increase should be \>40% for adults and \>30% for elderly subjects.
Secondary Outcomes
- Number of Subjects Reporting Local and Systemic Reactions(3 days postvaccination)