Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-000943-33-GB
• Date of registration: 28/03/2008
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur SA
• Public title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
• Scientific title: Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
• Date of first enrolment: 23/04/2008
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000943-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1) Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or older (from the day of the 61st birthday) on the day of inclusion
2) Provision of a signed informed consent
3) Able to attend all scheduled visits and comply with all trial procedures
4) For a woman of child-bearing potential: avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 21 days after 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:
1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at V01
2) Febrile illness (temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
3) Breast-feeding woman
4) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination
5) Planned participation in another clinical trial during the present trial period
6) Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
7) Known systemic hypersensitivity to egg proteins, chick proteins, neomycin, formaldehyde and octoxinol 9, or to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing any of the same substances
8) Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
9) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures
10) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
11) Receipt of any vaccine in the 4 weeks preceding the trial vaccination
12) Planned receipt of any vaccine in the 3 weeks following the trial vaccination
13) Previous vaccination against influenza in the previous 6 months
14) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
15) Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen or Hepatitis C seropositivity
16) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent


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

Health Condition(s) or Problem(s) studied

Vaccination of healthy subjects aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion with one dose of the new formulation of the influenza vaccine for the 2008-2009 Northern Hemisphere season

Intervention(s)

Product Name: Influenza vaccine (split virion, inactivated)
Product Code: 314
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/59/2007 (H1N1)-like strain
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/10/2007 (H3N2)-like strain
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Other descriptive name: Influenza virus (split virion, inactivated) B/Florida/4/2006-like strain
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Secondary Objective: To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere 2008-2009 formulation.

Main Objective: To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.

Primary end point(s): For each vaccine strain:
• Individual titer ratio D21/D0,
• Seroprotection status: titer =40 (1/dil) on D0 and D21,
• Seroconversion for subjects with a titer <10 (1/dil) on D0: post-injection titer =40 (1/dil) on D21 or significant increase for subjects with a titer =10 (1/dil) on D0: =4-fold increase from pre- to post-injection titer on D21

Secondary ID(s)

GRT83