Seasonal Optaflu trial 2012/13

• Conditions: no medical condition, healthy volunteers will be recruited into the clincial trial for annual approval of influenza vaccine with the new strain composition according WHO and EMEA recommendation and CHMP critieria (CPMP/BWP/214/96); MedDRA version: 14.1Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-006277-25-DE
• Lead Sponsor: ovartis Vaccines and Diagnostics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-12
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Males and females volunteers of 18 years of age or 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 the outcome of medical history, physical
examination and clinical judgment of the investigator.
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 63
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 63

Exclusion Criteria

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:
Medically significant Cancer (except for benign or localized skin cancer, cancer in
remission for =10 years or localized prostate cancer that has been clinically stable for
more than 2 years without treatment)
Medically significant advanced congestive heart failure (ie. NYHA class III and IV)
Chronic obstructive pulmonary disease (COPD);
Autoimmune disease (including rheumatoid arthritis, except for Hashimoto's
thyroiditis that has been clinically stable for = 5 years)
Diabetes mellitus type I;
Poorly controlled diabetes mellitus type II;
Advanced arteriosclerotic disease;
History of underlying medical condition such as major congenital abnormalities
requiring surgery, chronic treatment, or associated with developmental delay (e.g.,Down’s syndrome);
Acute or progressive hepatic disease;
Acute or progressive renal disease;
Severe neurological (es. Guillain–Barré syndrome) or psychiatric disorder;
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. influenza viral protein, and exipients);
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:
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;
receipt of immunostimulants;
receipt of parenteral immunoglobulin preparation, blood products and/or plasma
derivates within the past 3 months and for the full length of the study;
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 potential do not plan to use acceptable birth control measures, for the
whole 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 with history or any illness that, in the opinion of the investigator, might
interfere with the results of the study or pose additional risk to the subjects due to
participation in the study.
10. Individuals Within the past 6 months, they have:
had any seasonal or pandemic laboratory confirmed influenza disease;
received any seasonal or pandemic influenza vaccine;
11. Individuals with any acute or chronic infections requiring systemic antibio

Study & Design

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