Preventive vaccination study in healthy subjects aged 18-60 years and over 60 years against infection with H5N1 Influenza Virus A/Indonesia/5/05-RG2 (H5N1)
Conditions
Interventions
Product Name: Pandemic Flu Vaccine (H5N1) (split virion, inactived, adjuvanted with AF03)
Product Code: 414
Pharmaceutical Form: Emulsion for injection
Other descriptive name: Inactived split influenz
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, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination, or having undergone a surgical sterilization or being post-menopausal 5) Covered by health insurance or entitled to national social security depending on local regulations 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) Known pregnancy, or a positive urine pregnancy test 2) Currently breastfeeding a child 3) Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination 4) Planned participation in another clinical trial during the present trial period 5) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination 6) Planned receipt of any vaccine prior to the blood sample performed 21 days after the second trial vaccination 7) Previous vaccination with an H5N1 vaccine 8) History of H5N1 infection or exposure to presumed/confirmed (either clinically, serologically, or microbiologically) cases of H5N1-infected humans or animals 9) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response 10) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as 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) 11) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C 12) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances 13) Self-reported thrombocytopenia, contraindicating IM vaccination 14) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the opinion of the investigator 15) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 16) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures 17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 18) 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. 19) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination 20) Receipt of any vaccine with an adjuvant (except for aluminum) in a context of a clinical trial in the past 2 years 21) Receipt of an A/H1N1 pandemic influenza vaccine in the context of the national pandemic vaccination campaign 2009-2010 22) Known or suspected autoimmune disease or systemic disease (e.g. Sjögren syndrome, lupus erythematosus, rhumatoïde arthritis, sarcoïdosis, vasculitis, etc…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To describe the safety profile of the vaccines (injection site reactions and systemic events) either 21 days after each injection in subjects vaccinated following the D0-D21 or D0-D42 schedules or, 14 days and 21 days after the first and second injection respectively, in subjects vaccinated following the D0-D14 schedule • To describe the immunogenicity 21 days after each vaccine injection in a randomized subset of subjects vaccinated following the D0-D21 schedule and participating to immunogenicity evaluation • To describe the persistence of antibodies (Ab) 6 and 12 months after the second vaccine injection in the randomized subset of subjects vaccinated following the D0-D21 schedule and participating to immunogenicity evaluation. ;Secondary Objective: Not applicable;Primary end point(s): Safety • Occurrence of unsolicited adverse event (AE) reported in the 30 minutes after each/any injection • Occurrence of solicited (prelisted in the subject diary and electronic Case Report Form [eCRF]) injection site reactions and systemic reactions within 7 days following each/any injection • Occurrence of unsolicited (spontaneously reported) AEs within 21 days following each/any injection in subjects vaccinated following the D0-D21 or D0-D42 schedules or, 14 days and 21 days after the first and second injection respectively, in subjects vaccinated following the D0-D14 schedule • Occurrence of the following solicited reactions (Medical Dictionary for Regulatory Activities [MedDRA] Preferred Terms given in parentheses) in the 3 days following each injection will be more specifically reported (as defined by the European Medicines Agency (EMEA) Note for Guidance [CPMP/BWP/214/96]): - Injection site induration =5 cm for at least 4 consecutive days following each injection - Injection site ecchymosis (injection site hemorrhage) in the 3 days following each injection - Temperature >38°C (pyrexia) for 24 hours or more in the 3 days following each injection | — |
Countries
Belgium, France, United Kingdom
Outcome results
None listed