A Phase III, multicenter, uncontrolled, open label study to evaluate safety and immunogenicity of FLUVIRIN® [Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur], Formulation 2010/2011, when administered to adult and elderly subjects. - FLUVIRIN® 2010-2011 seasonal trial

Active, not recruiting

• Conditions: Prophylaxis of influenza; MedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2010-019040-39-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Subjects eligible for enrollment into this study are male and female adults who are
1. 18 years of age and older, mentally competent, willing and able to give written informed consent prior to study entry;
2. Individuals able to comply with all the study requirements;
3. Individuals in good health as determined by medical history, physical examination and clinical judgment of the investigator.

Written informed consent must be obtained for all the subjects before enrollment into 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

Exclusion Criteria

Subjects are not to be enrolled into the study if at least one of the following criteria is fulfilled:
1. Individuals with behavioral or cognitive impairment or psychiatric disease that,
in the opinion of the investigator, may interfere with the subject's ability to
participate in the study;
2. Individuals with any serious chronic or acute disease (in the judgment of the
investigator), 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;
3. Individuals with 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, polymyxin, neomycin)
4. Individuals with 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 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 derivates within the past 3 months and for the full length of the
study;
d. suspected or known HIV infection or HIV-related disease;
5. Individuals with known or suspected history of drug or alcohol abuse;
6. Individuals with a bleeding diathesis or conditions associated with prolonged
bleeding time that in the investigator’s opinion would interfere with the safety of the
subject;
7. Female who are pregnant or nursing (breastfeeding) mothers or females of
childbearing age do not plan to use acceptable birth control measures, for the
duration of the study. Adequate contraception is defined as hormonal (e.g., oral,
injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with
spermicide or diaphragm with spermicide),,intrauterine device (IUD), or monogamous relationship with vasectomized partner who has been vasectomized for 6 months or more prior to the subject’s study entry;
8. Individuals who are not able to comprehend and to follow all required study
procedures for the whole period of the study;
9. Individuals that within the past 12 months have received more than one injection
of influenza vaccine;
10. Individuals that within the past 6 months have:
a. had laboratory confirmed seasonal or pandemic influenza disease;
b. received seasonal or pandemic influenza vaccine;
11. Individuals with any acute or chronic infections requiring systemic antibiotic
treatment or antiviral therapy within the last 7 days
12. Individuals that have experienced fever (i.e., axillary temperature = 38°C) within
the last 3 days of intended study vaccination
13. Individuals participating in any clinical trial with another investigational product
4 weeks prior to first study visit or intent to participate in another clinical study at
any time during the conduct of this study.
14. Individuals who received any other vaccines within 4 weeks prior to enrollment
in this study or who are planning to receive any vaccine within 4 weeks from the
study v

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified