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 intraderma 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/California/7/200
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: 1) Aged 18 years or over on the day of inclusion 2) Informed consent form has been signed and dated 3) Able to attend all scheduled visits and to comply with all trial procedures 4) For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks 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
Exclusion criteria: An individual fulfilling any of the following criteria is to be excluded from trial enrollment: 1) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination 2) 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 vaccine used in the trial or to a vaccine containing any of the same substances 3) Known pregnancy, or a positive urine pregnancy test 4) Currently breastfeeding a child 5) History of pandemic H1N1 influenza vaccination 6) History of clinically or laboratory confirmed pandemic H1N1 influenza infection 7) History of influenza vaccination within the previous 6 months (other than pandemic H1N1 influenza vaccine) 8) Receipt of an adjuvanted influenza vaccine in a clinical trial within the previous 12 months 9) Known or suspected congenital or acquired immunodeficiency, resulting for example from: - End-stage renal disease requiring dialysis - Active neoplastic disease or active hematologic malignancy - Receipt of immunosuppressive therapy or other immune-modifying drugs such as, but not limited to: anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) 10) History of seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C 11) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response 12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 13) Receipt of any vaccine in the 4 weeks preceding the trial vaccination 14) Planned receipt of any vaccine in the 3 weeks following the trial vaccination 15) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial vaccination 16) Planned participation in another clinical trial during the present trial period 17) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 18) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures 19) Identified as 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 (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Main Objective: In each group: 1) To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the ID influenza vaccine NH 2010-2011 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 2010-2011 formulation;Primary end point(s): Immunogenicity : 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 two independent assays on day (D) 0 and D21 samples, summarized at the subject level by individual geometric mean of the two titers on D0 and D21. The derived endpoints will be: - Individual titer ratio D21/D0, - Seroprotection status: titer =40 (1/dilution [1/dil]) on D0 and D21, - Seroconversion for subjects with a titer 38°C for 24 hours or more - Malaise - Shivering - Occurrence of unsolicited adverse events (AEs) reported in the 30 minutes after injection - Occurrence of solicited (prelisted in the subject diary and electronic Case Report Form [CRF]) injection site reactions and systemic reactions within 7 days following injection - Occurrence of unsolicited (spontaneously reported) AEs within 21 days following injection - Occurrence of serious adverse events (SAEs) between V01 up to the end of the trial Others endpoints recorded or derived will be described at the time of statistical analysis plan. Depending on the item, these could include: nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), time of onset, duration, number of days of occurrence, Grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome. | — |
Countries
Belgium
Outcome results
None listed