Immunization against influenza disease during pandemic in subjects over 60 years of age. MedDRA version: 6.1 Level: PT Classification code 10022000
Conditions
Interventions
Product Name: Influenza Monovalent Split Virus H5N1 vaccine adjuvanted with AS03
Pharmaceutical Form: Suspension for injection
Other descriptive name: HA from A/Vietnam/1194/2004 H5N1 NIBRG-14
Con
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes that they can and will comply with the requirements of the protocol e.g., completion of the diary cards, return for follow-up visits should be enrolled in the study. A male or female aged 61 years or above at the time of the first vaccination. Written informed consent obtained from the subject. Healthy subjects or subjects with well controlled underlying disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: Administration of licensed vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination with H5N1 vaccine. Chronic administration defined as more than 14 days of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine. For corticosteroids, this will mean prednisone, or equivalent, 8805; 0.5 mg/kg/Day. Inhaled and topical steroids are allowed . Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination no laboratory testing required . History of chronic alcohol consumption and/or drug abuse. History of hypersensitivity to vaccines. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including egg and thiomersal allergy . Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever defined as axillary temperature 8805;37.5 C . Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. Subjects suffering from seasonal allergies or asthma under inhalative treatment can be included, as well as subjects with well controlled underlying diseases . Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study. Use of any investigational or non-registered product drug or vaccine other than the study vaccine s within 30 days prior to the first vaccination, or planned use during the study period. Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunogenicity of the H5N1 vaccine administered as a single or double dose in terms of humoral immune response anti-haemagglutinin antibody and neutralizing antibody 21 days after each vaccination. To assess the persistence of antibodies 180 days after the first vaccination with the H5N1 vaccine Refer to Section 10.1 for definition of the primary endpoint.;Secondary Objective: Evaluate the safety/reactogenicity of the H5N1 vaccine administered as a single or double-dose in terms of 8722; Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-Day follow-up period i.e. Day of vaccination and 6 subsequent days after each dose of vaccine and overall. 8722; Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during 21 days following the first H5N1 vaccination i.e. Day of first vaccination and 20 subsequent days and during 30 days following the second vaccination. 8722; Occurrence of serious adverse events SAEs during the entire study period. To evaluate the safety of the H5N1 vaccine administered as a single or double-dose based on haematological and biochemical parameters. To evaluate at days 0, 21, 42 and 180, the cell-mediated immune response in terms ofTh1-specific activation marker expression;Primary end point(s): Geometric mean titres GMTs of H5N1 antibody titres at days 0, 21, 42 and 180 Seroconversion rates SC at days 21, 42 and 180. In addition, humoral immune response in term of anti-HA antibodies will be evaluated using the following parameters with 95 CIs Seroconversion factors at days 21, 42 and 180 Seroprotection rates at days 0, 21, 42 and 180 | — |
Countries
Italy
Outcome results
None listed