A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old. - FLU-LD-004

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2006-003769-15-BE
• Date of registration: 03/08/2006
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old. - FLU-LD-004
• Scientific title: A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old. - FLU-LD-004
• Date of first enrolment: 06/09/2006
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003769-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Belgium

Key inclusion & exclusion criteria

Inclusion criteria:
A male or female aged 18-59 years old at the time of the vaccination.

Free of obvious health problems as established by medical history and clinical examination before entering into the study.

If the subject is female, she must be of non-childbearing potential
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) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Use of any investigational or non-registered product within 30 days preceding the administration of the study vaccine, or planned use during the study period.
•Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
•Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period.
•Administration of other licensed vaccines within 30 days prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol during the study period.
•History of hypersensivity to a previous dose of influenza vaccine.
•Previous vaccination against influenza in 2006.
•History of confirmed influenza infection within the last 12 months.
•History of allergy or reactions likely to be exacerbated by any component of the vaccines
•Pregnancy.
•Acute disease at the time of enrolment. History of administration of an experimental/licensed vaccine containing squalene and/or tocopherol (Vitamin E) within the last 12 Months.




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Immunization against influenza in male and female subjects aged 18-59 years old.

Intervention(s)

Product Name: GlaxoSmithKline Biologicals low dose influenza vaccine adjuvanted with AS03 (full dose of AS03)
Product Code: FLU-LD
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/New Caledonia/20/99 (IVR-116)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Haemagglutinin from A/Wisconsin/67/2005 (NYMCX-161)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Haemagglutinin from B/Malaysia/2506/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Product Name: GlaxoSmithKline Biologicals low dose influenza vaccine adjuvanted with AS03 (half dose of AS03)
Product Code: FLU-LD
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/New Caledonia/20/99 (IVR-116)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Haemagglutinin from A/Wisconsin/67/2005 (NYMCX-161)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
INN or Proposed INN: Haemagglutinin from B/Malaysia/2506/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Alpharix
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Haemagglutinin from A/New Caledonia/20/99 (IVR-116)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: Haemagglutinin from A/Wisconsin/67/2005 (NYMCX-161)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: aemagglutinin from B/Malaysia/2506/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Main Objective: To assess the humoral immune response (anti-haemagglutinin antibody titres) elicited by the low dose influenza vaccine adjuvanted with AS03 (full or half dose of AS03) and by Fluarix given intramuscularly in subjects aged 18-59 years old, 21 days following vaccination.

Primary end point(s): •At days 0 and 21: serum haemagglutination-inhibition (HI) antibody titre, against each of the three vaccine strains, in each group.

Secondary Objective: To assess the safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 (full or half dose of AS03) and Fluarix during 30 days following the intramuscular administration of the vaccines in subjects aged 18-59 years old.

Secondary ID(s)

108656