Influenza disease.
Conditions
Interventions
Trade Name: Optaflu
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/Solomon Islands/3/2006 (H1N1) influenza strain
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
Novartis Vaccines and Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.subjects 18 to 49 years of age; 2.in good health as determined by medical history and a physical examination; 3.able and willing to provide written informed consent prior to any study procedure; 4.able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection nasal and throat specimens in the event of influenza symptoms. 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: 1.history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex); 2.any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy; 3.employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person; 4.history of Guillain-Barré syndrome; 5.bleeding diathesis; 6.receipt of another investigational agent within 90 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 study; 7.receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1; 8.laboratory-confirmed influenza disease within 6 months prior to Visit 1; 9.receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study; 10.experienced a temperature (=100.0°F / =37.8°C) and/or any acute illness within 3 days prior to study vaccination; 11.pregnant or breast-feeding female; 12.if female of childbearing potential and sexually active, has not used any of the birth control methods detailed in the section entitled “Females of Childbearing Potential” for at least 2 months prior to study entry; 13.if female of childbearing potential and sexually active, refusal to use a reliable contraceptive method as detailed in the section entitled “Females of Childbearing Potential” during the first 3 weeks after vaccination; 14.research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.; 15.any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or with the safety of the study subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To demonstrate protection of a cell-derived influenza vaccine compared to placebo against illness caused by virus-confirmed community-acquired influenza wild type strains antigenically similar to those contained in the vaccines. •To demonstrate protection of an egg-derived influenza vaccine compared to placebo against illness2 caused by virus-confirmed community-acquired influenza wild type strains antigenically similar to those contained in the vaccines. ;Secondary Objective: Efficacy •To evaluate protection against illness2 caused by all virus-confirmed community-acquired influenza wild type strains regardless of antigenic match to those contained in the vaccines. •To evaluate protection against illness2 caused by virus-confirmed community-acquired influenza wild type strains dissimilar to those contained in the vaccines. •To evaluate protection against illness that does not match the CDC case definition2 caused by all virus-confirmed community-acquired influenza wild type strains that are either antigenically similar, dissimilar or regardless of antigenic match to those contained in the vaccines. •To evaluate whether the number of days in bed, medical visits and number of days of usual activity lost due to influenza is reduced. Immunogenicity •To evaluate immunogenicity (in a subset of subjects). Safety •To evaluate safety and tolerability of a cell-derived and egg-derived influenza vaccine compared to placebo.;Primary end point(s): Measures of efficacy Number and percentages of subjects with virus-confirmed influenza disease. | — |
Countries
Finland
Outcome results
None listed