A phase III, multicenter, uncontrolled, open label study to demonstrate safety, tolerability and immunogenicity of the Chiron Behring preservative free inactivated split influenza vaccine using the strain composition 2005/2006 - 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
- EUCTR2005-000430-20-DE
- Lead Sponsor
- Chiron Behring GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 120
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
2. have given the written informed consent prior to the study entry and after the nature of the study has been explained
3. available for all the visits scheduled in the study
4. 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.
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. history of cancer (leukemia, lymphomas, neoplasm)
b. congestive heart failure
c. advanced arteriosclerotic disease
d. COPD requiring oxygen therapy
e. autoimmune disease
f. insulin dependent diabetes mellitus
g. acute or progressive hepatic disease
h. acute or progressive renal failure
2. They have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component.
3. They have a known or suspected impairment/alteration of immune function resulting for example from:
a. receipt of immunosuppressive therapy (any systemic cortical steroid or cancer chemotherapy) 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.
4. They have a known or suspected history of drug or alcohol abuse.
5. They have a bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
6. 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).
7. Within the last 6 months they have
a) had laboratory confirmed influenza disease
b) have been vaccinated against influenza
8. Within the last 4 weeks they have received
a) another vaccine
b) any investigational agent
9. They have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the last 14 days.
10. They have experienced an acute exacerbation of a COPD (chronic obstructive pulmonary disease) within the last 14 days.
11. They have experienced fever (i.e. body temperature ³ 38.0°C) within the past 3 days.
12. They are taking part in another clinical study.
13. 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