A Phase III, Multicenter, Uncontrolled, Open-label study to evaluate Safety and Immunogenicity of Begrivac, preservative free inactivated Split Influenza Vaccine, using the Strain Composition 2006/2007 when administered to Non-elderly Adult and Elderly Subjects - n/a
- Conditions
- no medical conditionhealthy volunteers will be recruited into clinical trial for annual approval of Influenza vaccine with new strain composition according to WHO and EMEA recommendation and CPMP criteria (Note for Guidance on Harmonisation of Requirements for Influenza Vaccines, 12 March 1997, CPMP/BWP/214/96), Influenza vaccine for prevention of Influenza
- Registration Number
- EUCTR2006-000438-11-DE
- Lead Sponsor
- Chiron Behring GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects eligible for enrollment into this study are male and female adults who are
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
Informed consent must be obtained from all the subjects before enrollment in the study after the nature of the study has been explained.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
1. They have any serious chronic disease such as:
a. cancer (leukemia, lymphomas, neoplasm), except for benign or localized skin cancer and non metastatic prostate cancer not presently treated with chemotherapy
b. congestive heart failure
c. advanced arteriosclerotic disease
d. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy
e. autoimmune disease (including rheumatoid arthritis)
f. insulin dependent diabetes mellitus
g. acute or progressive hepatic disease
h. acute or progressive renal disease
2. They have a history of any anaphylaxis, serious vaccine reactions, are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine .
3. They have a history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine
4. They have a 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:
a. receipt of immunosuppressive therapy (any parenteral or oral corticosteroid or cancer chemotherapy/radiotherapy) within the last 2 months and for the full length of the study,
b. receipt of immunostimulants,
c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
d. suspected or known HIV infection or HIV-related disease.
5. They have a known or suspected history of drug or alcohol abuse.
6. They have a bleeding diathesis or receive anticoagulants of the coumarin type.
7. Women who are pregnant or who could become pregnant during the study but are not willing to practice acceptable contraception for the duration of the study (21 days).
8. within the past 12 months, they have received more than one injection of influenza vaccine
9. Within the last 6 months they have
a. had laboratory confirmed influenza disease
b. have been vaccinated against influenza
10. Within the last 4 weeks they have received
a. another vaccine
b. any investigational agent
11. They have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
12. They have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the last 14 days.
13. They have experienced fever (i.e. body temperature = 38.0°C) within the past 3 days.
14. They are taking part in another clinical study.
15. They have any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method