Vaccination of adults (18-60 years) and elderly (>60 years) with pandemic flu H5N1 vaccine.
Conditions
Interventions
Product Name: A/H5N1 inactivated, adjuvanted, split virion influenza vaccine made in embryonated eggs
Product Code: 402
Pharmaceutical Form: Suspension for injection
Other descriptive name: Inactivate
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged over 18 years on the day of inclusion, and 18 to 60 years for the 50 additional subjects for A/Indonesia primary series. 2) Informed consent form signed. 3) Able to attend all scheduled visits and to comply with all trial procedures. 4) For a woman, inability to bear a child or negative urine pregnancy test. 5) For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior and at least 4 weeks after to each vaccination. 6) Addendum 1 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04 for subjects who are to receive a booster at M6 or later). 7) Addendum 2 of the informed consent form signed and dated by the subject (this inclusion criteria has to be checked only at V04_Add for subjects who are to receive a A/Indonesia booster. 8) Addendum 3 of the Informed Consent Form signed and dated by the subject (this inclusion criterion has to be checked only at V05 for subjects who are to receive a A/Indonesia booster). 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) Systemic hypersensitivity to any component of the vaccine or a life-threatening reaction after previous administration of a vaccine containing the same substances (egg proteins, chick proteins, thimerosal, aluminum, neomycin, formaldehyde, and octoxinol 9). 2) Febrile illness (oral temperature =37.5°C) on the day of inclusion. 3) Breast-feeding. 4) Previous vaccination with an avian flu vaccine. 5) Participation in a clinical trial (drug, device, or medical procedure) within 4 weeks prior to the first vaccination. 6) Planned participation in another clinical trial during the present trial period. 7) 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. 8) Chronic illness that could interfere with trial conduct or completion (e.g. cardiac, renal, diabetes, or auto-immune disorders). 9) Current alcohol or drug abuse that may interfere with the subject’s ability to comply with trial procedures. 10) Receipt of blood or blood-derived products within the past 3 months. 11) Any vaccination within 4 weeks prior to the first trial vaccination. 12) Vaccination planned within 4 weeks after any trial vaccination. 13) Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. 14) Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To describe the injection site reactions and systemic safety profile during the 21 days following each of 2 primary series and 1 booster (as applicable) intramuscular injections in 2 age groups: subjects aged 18 to 60 yrs (adults) or >60 yrs (elderly) •To describe the immune response 21 days after each of 2 primary series IM injections in 2 age groups: subjects aged 18 to 60 yrs and >60 yrs •To describe the antibody persistence at M6 (D180) (all subjects), M15 and M22 (subsets of subjects) after the first vaccination in two age groups: subjects aged 18 to 60 years (adults) or >60 years (elderly) •To describe the immune response 21 days after a booster vaccination administered at 6 mths (A/Vietnam booster) or 7 and 21 days after a booster vaccination administered at 22 mths (A/Indonesia booster) after the first vaccination in 2 age groups: subjects aged 18 to 60 yrs or >60 yrs •To describe any serious adverse events during entire trial;Secondary Objective: No secondary objective;Primary end point(s): Safety •The occurrence, time to onset, number of days of occurrence, and severity of solicited (prelisted in the subject diary and Case Report Form) injection site reactions and systemic reactions occurring within 7 days following each injection will be reported. •The occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA]preferred term), time to onset, duration, severity, relationship to vaccination and seriousness of unsolicited (spontaneously reported) adverse events (AEs) within 21 days following each injection will be reported. •The occurrence of the following reactions (MedDRA Preferred Terms given in parentheses) in the 3 days following each injection will be more especially reported (as defined by the European Medicines Agency Note for Guidance [CPMP/BWP/214/96]): •Injection site induration >5 cm observed for more than 3 days. •Injection site ecchymosis (injection site hemorrhage). •Rectal equivalent temperature >38°C for 24 ho | — |
Countries
Belgium, United Kingdom
Outcome results
None listed