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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	19 March 2012
Main ID:	EUCTR2007-007043-27-EE
Date of registration:	28/12/2007
Prospective Registration:	Yes
Primary sponsor:	GlaxoSmithKline Biologicals
Public title:	A phase II, double-blind, multicentre, randomized study to demonstrate the non-inferiority of GlaxoSmithKline Biologicals’ thiomersal-free adjuvanted influenza vaccine compared to GlaxoSmithKline Biologicals thiomersal-reduced adjuvanted influenza vaccine in adults aged 65 years and above - FLU-AS25-026 PRI
Scientific title:	A phase II, double-blind, multicentre, randomized study to demonstrate the non-inferiority of GlaxoSmithKline Biologicals’ thiomersal-free adjuvanted influenza vaccine compared to GlaxoSmithKline Biologicals thiomersal-reduced adjuvanted influenza vaccine in adults aged 65 years and above - FLU-AS25-026 PRI
Date of first enrolment:	21/02/2008
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-007043-27
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
Phase:

Countries of recruitment
Estonia

Contacts

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Key inclusion & exclusion 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) should be enrolled in the study.
A male or female 65 years of age or older at the time of vaccination.
Written informed consent obtained from the subject.
Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

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:
•Suspected or confirmed influenza infection within the last 6 months.
•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.
•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 a vaccine not foreseen by the study protocol up to 21 days after vaccination.
•Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
•Previous vaccination against influenza with any seasonal vaccine since July 2007.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >/= 0.5 mg/kg/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) including egg and chicken protein.
•Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
•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).
•Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
•Any medical conditions in which IM injections are contraindicated

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 >/= 65 years.

Intervention(s)

Product Name: GlaxoSmithKline thiomersal reduced influenza vaccine adjuvanted with AS25
Product Code: TR FluAS25
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Haemagglutinin from A/Solomon Islands/3/2006 (IVR-145)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 21.4-
INN or Proposed INN: Haemagglutinin from A/Wisconsin/67/2005 (NYCMCX-161B)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 21.4-
INN or Proposed INN: Haemagglutinin from B/Malaysia/2506/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 21.4-

Product Name: GlaxoSmithKline Biologicals thiomersal fre influenza vaccine adjuvanted with AS25
Product Code: TF FluAS25
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Haemagglutinin from A/Solomon Islands/3/2006 (IVR-145)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 21.4-
INN or Proposed INN: Haemagglutinin from A/Wisconsin/67/2005 (NYCMCX-161B)
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 21.4-
INN or Proposed INN: Haemagglutinin from B/Malaysia/2506/2004
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 21.4-

Primary Outcome(s)

Secondary Objective: To assess the immunogenicity (GMT, seropositivity rate, seroconversion factor, seroconversion rate and seroprotection rate) of the thiomersal-free and the thiomersal-reduced AS25 adjuvanted influenza vaccines, 21 days after vaccination in subjects aged >/= 65 years.
To assess the safety and reactogenicity in subjects aged >/= 65 years vaccinated with the thiomersal-free and the thiomersal-reduced AS25 adjuvanted influenza vaccines, during the entire study period.

Main Objective: To demonstrate the immunological non-inferiority (in terms of HI antibody GMT) of the thiomersal-free AS25 adjuvanted influenza vaccine compared to the thiomersal-reduced AS25 adjuvanted influenza vaccine 21 days after vaccination in subjects aged >/= 65 years.

Primary end point(s): •At days 0 and 21, serum haemagglutination-inhibition (HI) antibody titer, against the three vaccine strains, in the TF-FluAS25 and the TR-FluAS25 groups

Secondary Outcome(s)

Secondary ID(s)

111454

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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