Vaccination of healthy children aged 6 months to 17 years with pandemic Flu H5N1 vaccine (30µgHA+aluminum hydroxide vaccine)
Conditions
Interventions
Product Name: FLU H5N1 30µgHA+aluminum hydroxide
Product Code: 402
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivated split influenza virus A/Indonesia/5/05-RG2 (H5N1)
C
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All Subjects: 1) Subject and parent(s)/legal representative able to attend all scheduled visits and to comply with all trial procedures 2) Completion of vaccination according to the national immunization schedule Subjects Aged =2 Years to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All subjects: 1) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding trial vaccination 2) Planned participation in another clinical trial during the present trial period 3) 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 4) Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances 5) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator 6) Current alcohol abuse or drug addiction that may interfere with the subject’s ability to comply with trial procedures 7) Receipt of Blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response 8) Receipt of any vaccine in the 4 weeks preceding trial vaccination 9) Planned receipt of any vaccine in the 4 weeks following any trial vaccination 10) (Known) Human Immunodeficiency Virus (HIV), HBs antigen or Hepatitis C seropositivity 11) Previous vaccination against avian influenza with either the trial vaccine or another vaccine 12) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination 13) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent 14) Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw Subjects Aged =2 Years to <18 Years: 15) For a female of child-bearing potential, known pregnancy or positive urine pregnancy test 16) Breast-feeding female 17) Febrile illness (temperature =37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment Subjects Aged =6 Months to <2 Years: 18) History of seizures 19) Febrile illness (temperature =38°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To describe the safety profiles (injection site reactions and systemic events) during the 21 days following each vaccination in subjects receiving the D0-D21 and the D0-D42 vaccination schedules, and 14 days and 21 days after Vac1 and Vac2, respectively, in subjects aged 9 to 17 years receiving the D0-D14 vaccination schedule • To describe the immune response 21 days after each vaccination in subjects receiving the D0-D21 vaccination schedule ;Secondary Objective: ;Primary end point(s): Safety: • Occurrence, nature, (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, severity (for non-serious AEs), action taken and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each injection • Occurrence, time to onset, number of days of occurrence, action taken and severity of solicited (pre-listed in the subject diary and Case Report Form [CRF]) injection site reactions and systemic reactions occurring up to 7 days following each injection • Occurrence, nature (MedDRA preferred term), time to onset, duration, severity (for non-serious AEs), action taken and relationship to vaccination of unsolicited (spontaneously reported) AEs within 21 days following each injection, as applicable* • Occurrence, nature, time to onset, duration, seriousness criteria, relationship to vaccination and outcome of serious adverse events (SAEs) during the whole study period • The occurrence of the following reactions (MedDRA Preferred Terms given in parentheses) following each injection will be more especially reported in subjects over 2 years of age (as defined for adults in 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 o | — |
Countries
Finland
Outcome results
None listed