no medical condition: healthy subjects
Conditions
Interventions
Trade Name: Optaflu
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza A/Solomon Islands/3/2006 (H1N1)-like virus
Concentration unit: µg microgram(s)
Concentration type: n
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry; 2. able to comply with all study procedures and requirements. 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: Exclusion criteria: 1. history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component; 2. fatal prognosis of an underlying medical condition (<12 months life expectancy); 3. history of Guillain-Barré syndrome; 4. bleeding diathesis or receiving anticoagulants of the coumarin type; 5. hospitalization or residence in a nursing care facility; 6. plans to receive seasonal influenza vaccine outside of this study; 7. receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study; 8. fever (defined as axillary temperature =38.0°C) or any acute illness within 3 days prior to study vaccination; 9. receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the observation period study; 10. any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives; 11. females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety Objective To compare the safety of a single intramuscular (IM) dose of the cell-derived influenza subunit vaccine (Optaflu®) with that of the egg-derived influenza subunit vaccine (Agrippal®) in adult and elderly subjects with and without underlying conditions. ;Secondary Objective: Immunogenicity Objective To evaluate the immunogenicity of Optaflu® and Agrippal® for each influenza vaccine strain, as measured by hemagglutination inhibition (HI) test 21 days after vaccination in a subset of adult and elderly subjects with underlying medical conditions. ;Primary end point(s): see E.2.1 an E.2.2 | — |
Countries
Germany
Outcome results
None listed