Preventive vaccination in healthy subjects aged 18 years and over against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)
Conditions
Interventions
Product Name: Swine A/H1N1 Influenza Vaccine (split virion, inactivated)
Product Code: 448
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (split virion, inactiva
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 the first vaccination until at least 4 weeks after the last 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) 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 Day 42 blood sample 7) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response 8) 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) 9) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C 10) 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 11) Self-reported thrombocytopenia, contraindicating IM vaccination 12) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination 13) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 14) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures 15) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 16) Employee 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 17) Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain 18) Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009 19) Febrile illness (temperature =38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment 20) Receipt of any allergy shots and/or seasonal allergy medication in the 7-day period prior to enrollment (vaccination), or scheduled to receive any allergy shots and/or seasonal allergy medication in the 7-day period after enrollment (vaccination)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To describe the immune response of each candidate vaccine 21 days after each vaccination by hemagglutination inhibition (HAI) and seroneutralization (SN) method in all adult and elderly subjects. • To describe the safety profiles (injection site reactions, and systemic events) of each candidate vaccine during the 21 days following each vaccination, and serious adverse events throughout the study in all adult and elderly subjects. ;Secondary Objective: Not applicable;Primary end point(s): Immunogenicity: Hemagglutination inhibition (HAI) method antibody (Ab) titers against the swine origin A/H1N1 strain measured with HAI method will be expressed as described below: • HAI Ab titers will be obtained on D0, D21, and D42. The following endpoints will be derived: • Individual titers ratios D21/D0, D42/D0, and D42/D21 • Subjects with HAI Ab titer =40 (1/dilution [dil]) on D0, D21, and D42 • Subjects with seroconversion or significant increase in HAI Ab titer, from D0 to D21 and from D0 to D42: • Seroconversion for subjects with a pre-vaccination titer 38°C (pyrexia) for 24 hours or more in the 3 days following each injection • Malaise in the 3 days following each injection • Shivering (chills) in the 3 days following each injection • Occurrence of SAEs including AESIs within the 21 days following each/any vaccination, and up to the end of the trial. | — |
Countries
France
Outcome results
None listed