Immunization of healthy adults against influenza MedDRA version: 14.1 Level: LLT Classification code 10059430 Term: Influenza immunization System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Influsplit Tetra / Fluarix Tetra
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: ANTIGENS OF THE INFLUENZA VIRUS A/CALIFORNIA/7/2009 (H1N1)-LIKE VI
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 - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause • 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: • Participation in previous year's Fluarix registration study (116663) • Use of any investigational or non-registered product (drug or vaccine) 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 immunemodifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed. • Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period. • 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 twelve months preceding the study vaccination. • Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine 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. - Fever is defined as temperature = 37.5°C/99.5°F on oral, axillary or tympanic setting, or = 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary. - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. • Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), 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 (no laboratory testing required). • History of Guillain-Barré syndrome. • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex. • 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 or would make intramuscular injection unsafe.
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 Tetra 2013/2014.;Secondary Objective: 1) To describe the reactogenicity and safety of Fluarix/Influsplit Tetra 2013/2014 in adults 18-60 years and >60 years of age, in terms of solicited adverse events (AEs), unsolicited AEs, and serious adverse events (SAEs). 2) To evaluate the humoral response (anti-HA antibodies tested by HI) against each vaccine strain, 21 days after vaccination, in adults 18-60 years and >60 years of age who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.;Primary end point(s): Humoral immune response in terms of anti-HA antibodies against each of the four vaccine influenza strains. The following parameters will be calculated with 95% confidence intervals (CIs): - Geometric mean titres (GMT) of anti-HA antibody titres - Seroprotection rates (SPR)* *SPR is defined as the percentage of vaccinees with serum HI titre = 1:40; usually accepted as indicating protection in at least 50% of the vaccinees. The following parameters will be calculated with 95% confidence intervals (CIs): - Seroconversion rates (SCR)* - Mean geometric increase ([MGI] also known as the Seroconversion factor [SCF])** - Seroprotection power (SPP)*** *SCR is defined as the percentage of vaccinees with either a pre-vaccination titre < 1:10 and a post-vaccination titre = 1:40 or a pre-vaccination titre = 1:10 and at least 4-fold increase in post-vaccination titre. **MGI or SCF is defined as the fold increase in serum HI geometric mean titres post-vaccination compared to Day 0. ***SPP is defined as the percentage of subjects who have a pre-vaccination titre < 1:40 and a post-vaccination titre = 1:40;Timepoint(s) of evaluation of this end point: At Day 0 and Day 21 po | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Reactogenicity: • 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 (SAEs) - Percentage, intensity and relationship to vaccination of SAEs 2) Humoral immune response in terms of anti-HA antibodies against each of the four vaccine influenza strains, in subjects aged 18-60 years and >60 years who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013. • The following parameters will be calculated with 95% CIs: - GMTs of anti-HA antibody titres and SPRs, in subjects who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.;Timepoint(s) of evaluation of this end point: • Solicited local and general symptoms: During a 4-day follow-up period after vaccination (Days 0-3) (i.e. day of vaccination and 3 subsequent days). • Unsolicited symptoms: During a 21-day follow-up period after vaccination (Days 0-20) (i.e. day of vaccination and 20 subsequent days. • Serious adverse events: During the entire study period (Day 0-Day 21) • Humoral immune response in subjects who have and who have not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013: At Day 0 and Day 21 post-vaccination | — |
Countries
Germany
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed