Seasonal Influenza Vaccine Clinical Trial
Official title:
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
| Verified date | January 2013 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Paul-Ehrlich-Institute |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 135 |
| Est. completion date | August 2007 |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Subjects eligible for enrollment into this study are male and female adults who were: 1. = 18 years of age, mentally competent, willing and able to give informed consent prior to study entry 2. available for all the visits scheduled in the study and able to comply with all study requirements 3. 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: 1. Any serious chronic or acute disease such as: 1. Cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non-metastatic prostate cancer not presently treated with chemotherapy 2. Congestive heart failure 3. Advanced arteriosclerotic disease 4. Chronic obstructive pulmonary disease (COPD) requiring oxygen therapy and/or acute exacerbation of a COPD within the last 14 days. 5. Autoimmune disease (including rheumatoid arthritis), if under immunosuppressive therapy (see below) 6. Insulin dependent diabetes mellitus 7. Acute or progressive hepatic disease 8. Acute or progressive renal disease 9. Severe neurological or psychiatric disorder 2. History of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine or chemically related substances 3. 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: 1. Receipt of immunosuppressive therapy (chronic therapy with immunosuppressive drugs, any parenteral or oral corticosteroid (substitution dose in case of absence of suprarenal function allowed) or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study, 2. Receipt of immunostimulants, 3. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, 4. Suspected or known HIV infection or HIV-related disease. 4. Known or suspected history of drug or alcohol abuse 5. Bleeding diathesis or receive anticoagulants of the coumarin type 6. Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days) 7. Influenza immunization or laboratory confirmed influenza within the last 6 months and more than one influenza immunization within the past 12 months 8. Immunization with any other vaccine and/or any investigational vaccine four weeks prior to study start 9. Any significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days 10. Fever (i.e. body temperature = 38.0°C) within the past 3 days prior to study entry 11. Simultaneous participation in another clinical study 12. Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Germany | Betriebsaerztlicher Dienst, Standort Marburg | Baldingerstrasse | Marburg Hessen |
| Germany | Z29, Blutspendezentrale, Gebaude Z29, Behringwerke | Emil-von-Behring-Str. 76 | Marburg |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Vaccines |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV). | 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. | 3 weeks postvaccination (Day 22) | No |
| Primary | Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV) | 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. |
3 weeks postvaccination (Day 22) | No |
| Primary | Percentages of Subjects With HI Titer =40 After 1 Dose of Cell Culture Derived Vaccine (cTIV). | 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. |
3 weeks postvaccination (Day 22) | No |
| Primary | Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV). | 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. |
3 weeks postvaccination (Day 22) | No |
| Secondary | Number of Subjects Reporting Local and Systemic Reactions | To evaluate the safety and tolerability of cell culture derived vaccine (cTIV) in adults and elderly subjects in terms of number of subjects reporting local and systemic reactions after 1 vaccine dose. | 3 days postvaccination | Yes |