Immunization against Influenza of healthy adults MedDRA version: 14.1 Level: LLT Classification code 10059430 Term: Influenza immunization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Fluarix/Influsplit SSW/alpha-rix
Pharmaceutical Form: Suspension for injection
Other descriptive name: A/California/7/2009 (H1N1)pdm09-like virus
Concentration unit: µg/ml microgram(s)/mi
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol. A male or female aged 18 years or above at the time of vaccination. Written informed consent obtained from the subject. Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60 ;Inclusion criteria: Subjects who the investigator believes can and will comply with the requirements of the protocol. A male or female aged 18 years or above at the time of vaccination. Written informed consent obtained from the subject. Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering the study. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period. Administration of an influenza vaccine within the six months preceding the study vaccination. Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period. Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. Acute disease and/or fever at the time of enrolment. Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Chronic underlying disease, not stabilized or clinically serious. History of chronic alcohol consumption and/or drug abuse. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of Guillain-Barré syndrome. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Anaphylaxis following the administration of vaccine(s). Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions. Any condition which, in the opinion of the investigator, prevents the subject from participating in the study. ;Exclusion criteria: Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study period. Administration of an influenza vaccine within the six months preceding the study vaccination. Planned administration/ administration of a vaccine other than the study vaccine within 30 days before study vaccination and during the entire study period. Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination. Acute disease and/or fever at the time of enrolment. Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Chronic underlying disease, not stabilized or clinically serious. History of chronic alcohol consumption and/or drug abuse. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. History of Guillain-Barré syndrome. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Anaphylaxis following the administration of vaccine(s). Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions. Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the humoral response (anti-haemagglutinin [HA] antibodies tested by Haemagglutination Inhibition [HI]) against each vaccine strain in adults 18-60 years and >60 years of age, 21 days after vaccination with Fluarix/Influsplit SSW 2012/2013.;Secondary Objective: To evaluate the humoral response (anti-HA antibodies tested by HI) against each vaccine strain, 21 days after vaccination, in adults >60 years of age who have not and who have received an influenza vaccine in the 2011-2012 season. To describe the reactogenicity and safety of Fluarix/Influsplit SSW 2012/2013 in adults 18-60 years and >60 years of age, in terms of solicited adverse events (AEs), unsolicited AEs and serious adverse events (SAEs). ;Primary end point(s): Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains. Geometric mean titres (GMTs) of anti-HA antibody titres. Seroprotection rates* (SPR). Seroconversion rates** (SCR). Mean geometric increase*** ([MGI] also known as the seroconversion factor [SCF]). Seroprotection power**** (SPP). *SPR: The percentage of vaccinees with serum HI titre = 1:40; usually accepted as indicating protection. **SCR: The percentage of vaccinees with either a pre-vaccination titre 60 years of age, 21 days after vaccination with Fluarix/Influsplit SSW 2012/2013.;Secondary Objective: To evaluate the humoral response (anti-HA antibodies tested by HI) against each vaccine strain, 21 days after vaccination, in adults >60 years of age who have not and who have received an influenza vaccine in the 2011-2012 season. To describe the reactogenicity and safety of Fluarix/Influsplit SSW 2012/2013 in adults 18-60 years and >60 years of age, in terms of solicited adverse events (AEs), unsolicited AEs and serious adverse events (SAEs). ;Primary end point(s): Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains. Geometric mean titres (GMTs) of anti-HA an | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains, by influenza vaccination status in the 2011-2012 season, in subjects aged >60 years. GMTs of anti-HA antibody titres and SPRs, by influenza vaccination status in the 2011-2012 season. SCRs and MGI by influenza vaccination status in the 2011-2012 season. Occurrence of solicited local and general symptoms Percentage, intensity and duration of solicited local symptoms. Percentage, intensity, duration and relationship to vaccination of solicited general symptoms. Occurrence of unsolicited symptoms Percentage, intensity and relationship to vaccination of unsolicited symptoms. Occurrence of serious adverse events Percentage, intensity and relationship to vaccination of SAEs. ;Timepoint(s) of evaluation of this end point: Humoral immune response: At Days 0 and 21 Solicited local and general symptoms: During the 4-day (Day 0-Day 3) follow-up period after vaccination Unsolicited symptoms: During the 21-day (Day 0-Day 20) follow-up period after vaccination Serious adverse events: During the 21-day (Day 0-Day 20) follow-up period after vaccination ;Secondary end point(s): Humoral immune response in terms of anti-HA antibodies against each of the three vaccine influenza strains, by influenza vaccination status in the 2011-2012 season, in subjects aged >60 years. GMTs of anti-HA antibody titres and SPRs, by influenza vaccination status in the 2011-2012 season. SCRs and MGI by influenza vaccination status in the 2011-2012 season. Occurrence of solicited local and general symptoms Percentage, intensity and duration of solicited local symptoms. Percentage, intensity, duration and relationship to vaccination of solicited general symptoms. Occurrence of unsolicited symptoms Percentage, intensity and relationship to vaccination of unsolicited symptoms. Occurrence of serious adverse events Percentage, intensity and relationship to va | — |
Countries
Germany
Contacts
Public ContactClinical Disclosure Advisor;Clinical Disclosure Advisor ;
GlaxoSmithKline Biologicals;GlaxoSmithKline Biologicals
Outcome results
None listed