Immunogenicity, reactogenicity and safety of the trivalent influenza subunit vaccine Influvac® for the season 2009/2010. An open-label, baseline-controlled multi-center study in two groups: adult subjects =18 and =60 years and elderly subjects =61 years of age. - Influvac Annual Update 2009/2010

• Conditions: Prophylaxis of Influenza; MedDRA version: 9.1Level: HLTClassification code 10022005Term: Influenza viral infections

• Registration Number: EUCTR2009-010900-27-BE
• Lead Sponsor: Solvay Biologicals BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.

2. Men and women aged = 18 and = 60 years or = 61 years of age at the day of study vaccination.

3. Being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on medication for a condition, the medication dose must have been stable for at least three months preceding study vaccination).

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

1. Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.

2. A serious adverse reaction after a previous (influenza) vaccination.

3. Presence of any significant condition that may prohibit inclusion as determined by the investigator.

4. Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.

5. A history of Guillain-Barré syndrome or active neurological disease.

6. Having fever and/or presenting with an acute disease or infection on the day of study vaccination.

7. Having any condition affecting the immune system e.g. autoimmune disease.

8. Receipt of vaccines (live or inactivated) within four weeks before study vaccination or planned vaccination (other than with the study vaccine) during the study period.

9. Using or having used medication that influences the immune system (such as corticosteroids) during the four weeks prior to the study or planned use thereof during the study. Topical use of corticosteroids (e.g. cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.

10. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination.

11. Receipt of another investigational agent within 30 days prior to study vaccination, or planned use during the study period.

12. Known drug or alcohol abuse

13. Planned surgery during the study period.

Exclusion criteria only for female subjects aged = 18 and = 60 years and of childbearing potential:
14. Being pregnant (positive urine pregnancy test at the day of study vaccination), breastfeeding or a desire to become pregnant during the study.

15. Not using a medically accepted method of birth control including abstinence during the study period.

Study & Design

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