Immunization against influenza in male and female subjects aged 65 years or older.
Conditions
Interventions
Trade Name: Fluarix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/Brisbane/59/2007 IVR-148
Concentration unit: µg/ml microgram(s)/millilitre
Concentration ty
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All subjects must satisfy the following criteria at study entry: • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. return for follow-up visits, disease reporting by phone, and completion of questionnaires) should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse. • A man or woman aged 65 years or older at the time of the vaccination. • Written informed consent obtained from the subject. • Subjects with residence status allowing free mixing with general community. 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • Bedridden subjects • Previous vaccination against influenza since February 2008. • Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine. • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. • Any contra-indication to intramuscular administration of the influenza vaccines. • History of hypersensitivity to a previous dose of influenza vaccine. • History of allergy or reactions likely to be exacerbated by any component of the vaccine including egg and chicken protein. • Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess in adults aged 65 years and above, the superior efficacy of the FLU NG vaccine after the first dose in the prevention of PCR-confirmed influenza A and /or B, due to any matching or drift influenza strain relative to the vaccine strains (i.e not emerging novel human influenza strain like H1n1v) during the corresponding surveillance period, when compared to Fluarix™. To assess the lot-to-lot consistency of 3 lots of the FLU NG vaccine in terms of immunogenicity (as measured by GMT), 21 days after vaccination during the first year of the study.;Secondary Objective: To evaluate the superior efficacy of FLU NG vaccine in the prevention of PCR and culture confirmed influenza (A, B) vs Fluarix due to any matching or drift influenza strain relative to the vaccine strains (i.e not emerging novel human influenza strain like H1n1v). During flu peak seasons, to evaluate the superior efficacy of FLU NG vaccine after first dose vs Fluarix™ in the prevention of: pneumonia or clinical flu; all-cause-death; hospitalization due to respiratory diseases. To evaluate immunogenicity (21 & 180 d) after each vaccination in a subset. To evaluate safety/reactogenicity in a subset: solicited AEs (7 d), AEs (21 d), AEs with medically attended visit (180 d) after each vaccination. To evaluate safety: SAEs and AEs of specific interest during the entire study period. ;Primary end point(s): • First occurrence of PCR confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e not emerging novel human influenza strain like H1n1v) after the first dose during the corresponding surveillance period. • At days 0 and 21 of the first year of the study, serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine strains, in the FLU NG groups (Geometric Mean Titres). | — |
Countries
Belgium, Czech Republic, Estonia, France, Germany, Netherlands, United Kingdom
Outcome results
None listed