To verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season, manufactured according to the standard manufacturing process using a fixed Trition-X concentration during the splitting process (Formula A) (Cohort 1) and a modified manufacturing process control using a fixed protein to Triton X-100 ratio during the splitting process of the H3N2 and the B strain (Formulation B) (Cohort 2) MedDRA
Conditions
Interventions
Product Name: Preflucel 2009/2010
Product Code: Preflucel 2009/2010
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Current Sponsor code: 720903
Other descriptive name: INFLUENZA VACCINE (
Sponsors
Baxter Innovations GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject is 18 to 59 years of age , inclusive, at the time of screening; Subject has given written informed consent prior to study entry; Subject is generally healthy , as determined by the investigator’s clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice; Subject agrees to keep a daily record of symptoms for the duration of the study; If female of childbearing potential, subject presents with a negative urine pregnancy test immediately prior to vaccination on Study Day 1 and agrees to employ adequate birth control measures for the duration of the study; Subject is willing and able to comply with the requirements of the protocol. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subject has a history of severe allergic reaction or anaphylaxis; Subject has an oral temperature of =37.5°C on the day of vaccination in this study; Subject has a dermatologic condition or tattoos, which may interfere with injection site reaction rating; Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry; Subject has been vaccinated with seasonal influenza vaccine for the 2009/2010 season. Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder ; Subject has any inherited or acquired immunodeficiency; Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs; Subject has a functional or surgical asplenia; Subject has a known or suspected problem with alcohol or drug abuse; Subject is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the investigator or site personnel conducting the study; If female, subject is pregnant or lactating at the time of study enrollment; Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Number of subjects with fever (=38.0°C), malaise or shivering with onset within 7 days after vaccination; Number of subjects with indurations larger than 50 mm in diameter and persisting for more than 3 days or ecchymosis with onset within 7 days after vaccination; ;Main Objective: To assess the safety of two formulations (Formulation A and Formulation B) of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season in an adult population through the first seven post vaccination days.;Secondary Objective: To assess the safety of two formulations (Formulation A and Formulation B) of a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season through the entire 21 day follow up period. To assess the immunogenicity to each of the three antigens contained in a trivalent seasonal influenza vaccine with strain composition according to WHO/EU recommendation for the 2009/2010 season in an adult population | — |
Countries
Austria, Belgium
Outcome results
None listed