Immunization against influenza in male and female adult subjects MedDRA version: 12.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: Pandemrix TM
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: A/California/7/2009 (H1N1)v NYMC X-179A
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type:
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 (e.g. completion of the diary cards, return for follow-up visits). Specific attention should be given to the compliance potential of subjects with suspected or known drug and alcohol abuse. •Subjects who have received one dose of Pandemrix at least 6 month before enrolment, to be enrolled in the PAN or FLU groups. •Subjects who have not been previously vaccinated with a vaccine against the pandemic H1N1 strain at all, to be enrolled in the CTRL (Fluarix) group. •A male or female 18 years and above at the time of enrolment. •Written informed consent obtained from the subject •Healthy subjects or free of acute aggravation of the health status as established by physical examination before entering into 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 from study inclusion up to 2 months after completion of the vaccination series. 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: •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. •Administration of any influenza vaccine within 6 month prior to vaccination in this study. •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. •Presence of an axillary temperature = 37.5ºC, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied. •Diagnosed with cancer, or treatment for cancer, within the past 3 years. -Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.(Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above. Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol). •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection. •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 10 mg/day of prednisone when administered for 2 weeks. Inhaled and topical steroids are allowed. •Any administration of a long-acting immune-modifying drug (e.g. rituximab, infliximab) within 3 months before study start, or a planned administration during the study period. •Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period. •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. •An acute evolving neurological disorder or history of Guillain-Barré syndrome. •Clinically or virologically confirmed influenza infection within 6 months preceding the study start. •Administration of any vaccines within 30 days before vaccination. •Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. •Pregnant or lactating female •Female planning to become pregnant or planning to discontinue contraceptive precautions from study inclusion up to 2 months after completion of the vaccination series. •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the humoral response in terms of haemagglutination inhibition (HI) antibodies against each influenza vaccine strain corresponding to the influenza vaccine administered, at Day 21, in subjects aged 18-60 and above 60 years.;Secondary Objective: •To evaluate the safety and reactogenicity (in terms of general and local solicited adverse events [AEs] 7 days after vaccination, unsolicited AEs 30 days after vaccination, serious adverse events [SAEs] and potential immune-mediated diseases [pIMDs] during the whole study period) in all subjects. •To evaluate the humoral response in terms of HI antibodies against each influenza vaccine strain corresponding to the influenza vaccine administered, before vaccination (Day 0), at Day 7 and Month 6 in subjects aged 18-60 and above 60 years ;Primary end point(s): •Humoral immune response in terms of HI antibodies for each vaccine strain, 21 days after vaccination in subjects aged 18-60 and above 60 years | — |
Countries
Germany
Outcome results
None listed