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 2008/2009 when administered to adult and elderly subjects
- Conditions
- o medical condition, healthy volunteers will be recruited into clinical trial for annual approval of influenza vaccine with the new strain composition accordng WHO and EMEA recommendation and CPMP criteria (CPMP/BWP/214/96)
- Registration Number
- EUCTR2008-000887-18-DE
- Lead Sponsor
- ovartis Vaccines and Diagnostics GmbH & Co KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
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
Written 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 (in the judgment of the investigator) disease, including but not limited to:
a.Cancer, except for localized skin cancer
b.Advanced congestive heart failure
c.Chronic obstructive pulmonary disease (COPD)
d.Autoimmune disease (including rheumatoid arthritis)
e.Acute or progressive hepatic disease
f.Acute or progressive renal disease
g.Severe neurological or psychiatric disorder
h.Severe Asthma
2.They have a history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
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:
a.receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days 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.Known or suspected history of drug or alcohol abuse.
5.They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator’s opinion would interfere with the safety of the subject;
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 vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
8.Within the past 4 weeks they have received:
-another vaccine
-any investigational agent;
9.Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
10.They have experienced fever (i.e., axillary temperature = 38°C) within the last 3 days
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.
13.Severely obese with Body Mass Index (BMI) > 35
14.Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
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