Vaccination of adults up to 59 years of age and elderly of 60 years of age and over with inactivated split-virion influenza vaccine administered by the intradermal route
Conditions
Interventions
Trade Name: INTANZA
Product Name: Intradermal Influenza Vaccine 9µg
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactivated) A/Brisbane/59/2007
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 59 years (i.e. to the day before the 60th birthday) or 60 years or older (from the day of the 60th 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 3 weeks after vaccination 5) Entitled to national social security 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: 1) For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test at V01 2) Febrile illness (temperature =38°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 eggs, chicken proteins, neomycin, formaldehyde and octoxynol-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 15) Known Human Immunodeficiency Virus (HIV), HBs 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 17) Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In subjects aged 18 to 59 years for the ID influenza vaccine 9 µg and in subjects aged 60 years or older for the ID influenza vaccine 15 µg: 1) To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the ID influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96. 2) To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.;Secondary Objective: Not applicable;Primary end point(s): Immunogenicity will be evaluated before and 21 days after injection of the ID influenza vaccine using the Hemagglutination Inhibition (HAI) technique. For each vaccine strain, anti-Hemagglutinin (HA) antibody titers will be expressed as HAI titers obtained in duplicate on D0 and D21, summarized at the subject level by individual geometric mean of duplicates on D0 and D21. The derived endpoints will be: • Individual titer ratio D21/D0, • Seroprotection status: titer =40 (1/dil) on D0 and D21, • Seroconversion for subjects with a titer 38°C for 24 hours or more • Malaise • Shivering • Occurrence of unsolicited AE reported in the 30 minutes after vaccination • Occurrence of solicited (prelisted in the subject diary and Case Report Form [CRF]) injection site reactions and systemic reactions within 7 days following vaccination • Occurrence of unsolicited (spontaneously reported) AEs within 21 days following vaccination, • Occurrence of SAEs from V01 up to the end of the trial | — |
Countries
France
Outcome results
None listed