Immunization against influenza in male and female subjects aged 19-43 years and 66 years or older.
Conditions
Interventions
Trade Name: Fluarix
Product Code: J07BB02
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/Brisbane/59/2007 IVR-148
Concentration unit: µg/ml microgram(s)/milli
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, reporting by phone) should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse. •A male or female aged 19-43 years or 66 years or older at the time of the vaccination and who participated in the 111737 study and completed the 6-month follow-up. •Written informed consent obtained from the subject. •Free of an acute aggravation of the health status as established by clinical evaluation (medical history and 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 for 2 months after the 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 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(s) within 30 days prior to vaccination, or planned use during the study period. •Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period. •Vaccination against influenza since January 2009 with a seasonal influenza vaccine. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, >/=20 mg/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 hypersensivity to a previous dose of influenza vaccine. •History of allergy or reactions likely to be exacerbated by any component of the vaccine(s). •Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation (medical history and physical examination) or pre-existing laboratory screening tests. •Acute disease and/or fever at the time of enrolment. ? Fever is defined as temperature =37.5°C on oral setting. ? Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. •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. •Any medical conditions in which IM injections are contraindicated •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and reactogenicity during the entire study period in subjects aged 66 years or older (previously enrolled in the 111737 study) vaccinated with the FLU NG vaccine or with Fluarix, and in subjects aged 19-43 years (previously enrolled in the 111737 study) vaccinated with Fluarix;Secondary Objective: •To assess the humoral immunogenicity 21 days following vaccination in subjects aged 66 years or older (previously enrolled in the 111737 study) vaccinated with the FLU NG vaccine or with Fluarix, and in subjects aged 19-43 years (previously enrolled in the 111737 study) vaccinated with Fluarix. •To evaluate the persistence of haemagglutination-inhibition (HI) antibodies 180 days after vaccination in each group. •To evaluate the Cell-Mediated Immune (CMI) response at Days 0, 21 and 180, in a sub-cohort of subjects, in each group.;Primary end point(s): •Solicited local and general symptoms ? Occurrence, intensity and duration of solicited local AEs during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination. ? Occurrence, intensity, duration and relationship to vaccination of solicited general AEs during a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after vaccination. •Unsolicited adverse events ? Occurrence, intensity and relationship to vaccination of unsolicited AEs during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent days) after vaccination. •Predefined adverse events ? Occurrence, intensity and relationship to vaccination of AEs with medically attended visit during a 180-day follow-up period (i.e. day of vaccination and 179 subsequent days) after vaccination. ? Occurrence, intensity and relationship to vaccination of AEs of specific interest during the entire study period. ? Serious adverse events ? Occurrence and relationship to vaccination of SAEs during the entire study period. | — |
Countries
Germany, Netherlands, Sweden
Outcome results
None listed