EUCTR2009-010900-27-DEActive, not recruitingNot Applicable
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
Solvay Biologicals BV0 sites120 target enrollmentStarted: March 31, 2009Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
Similar Trials
Active, not recruiting
Not Applicable
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 2009/2010Prophylaxis of InfluenzaMedDRA version: 9.1Level: HLTClassification code 10022005Term: Influenza viral infectionsEUCTR2009-010900-27-BESolvay Biologicals BV120
Active, not recruiting
Phase 1
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2013/2014 SeasoEUCTR2013-000881-12-BEAbbott Biologicals B.V130
Active, not recruiting
Not Applicable
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 2012/2013 SeasoEUCTR2012-001032-57-DEAbbott Biologicals B.V.130
Active, not recruiting
Not Applicable
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. 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 2008/2009EUCTR2008-001038-28-BESolvay Biologicals BV120
Active, not recruiting
Not Applicable
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Season 2008/2009. 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 2008/2009EUCTR2008-001038-28-DESolvay Biologicals BV120