Prophylaxis of Influenza MedDRA version: 12.1 Level: HLT Classification code 10022005 Term: Influenza viral infections
Conditions
Interventions
Trade Name: Influvac® 2010/2011
Product Name: Influvac 2010/2011
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Influenza vaccine (surface antigen, inactivated)
Current Sponsor cod
A/Perth/16/2009 (H3N2)-like strain
B/Brisbane/60/2008-like strain
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 15 µg per strain-
Sponsors
Abbott Biologicals B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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. Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection 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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: To determine the immunogenicity of the trivalent influenza subunit vaccine Influvac® for the season 2010/2011, in two groups: - Adult subjects aged =18 and = 60 years. - Elderly subjects = 61 years of age. Safety Objective: To collect data on the safety and tolerability (reactogenicity and overall inconvenience) of Influvac®. ;Secondary Objective: None;Primary end point(s): Anti-HA antibody response is an established correlate of protection against influenza. Therefore, the primary efficacy variable will be HI titers and its derived parameters as defined by the CHMP guideline for influenza vaccines. The following serological parameters will be derived from the individual HI antibody titers, separately for each strain: - the pre-and post-vaccination seroprotection rates, with seroprotection defined as an HI titer = 40 - the seroconversion rate, with seroconversion defined as a pre-vaccination HI titer 70% > 60% Seroconversion/4-fold increase rate: > 40% > 30% Mean fold increase: > 2.5 > 2.0 | — |
Countries
Germany
Outcome results
None listed