Preventive vaccination in healthy subjects aged 18 to 60 years against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)
Conditions
Interventions
Trade Name: PANENZA
Product Name: Swine A/H1N1 Influenza Vaccine (split virion, inactivated)
Product Code: 448
Pharmaceutical Form: Suspension for injection
Other descriptive name: Influenza virus (sp
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 to 60 years 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 from at least 4 weeks prior to vaccination until at least 4 weeks after 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) no 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 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 trial vaccination 6) Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response 7) 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) 8) Self-reported seropositivity for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 9) Known systemic hypersensitivity 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 10) Self-reported thrombocytopenia, contraindicating IM vaccination 11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination 12) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 13) Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures 14) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 15) 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 16) Subject previously vaccinated with an A/H1N1 pandemic influenza vaccine during vaccination campaign or in clinical trial 17) Personal history of influenza infection since May 2009 18) Febrile illness (temperature =38.0°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 immune response of the inactivated, split-virion swine-origin A/H1N1influenza vaccine without adjuvant in each group ;Secondary Objective: Not applicable;Primary end point(s): Immunogenicity: Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method will be expressed as described below: - HAI Ab titers will be obtained on D0 and D21. The following endpoints will be derived: - Individual titers ratio D21/D0 - Subjects with HAI Ab titer =40 (1/dilution [dil]) on D0 and D21 - Subjects with seroconversion or significant increase in HAI Ab titer, from D0 to D21: . Seroconversion for subjects with a pre-vaccination titer <10 (1/dil) on D0, post-vaccination titer =40 (1/dil) or . Significant increase for subjects with a pre-vaccination titer =10 (1/dil), =four-fold increase of the titer (post/pre) - Subjects with detectable HAI Ab, i.e. with a titer =10 (1/dil), on D0 and D21 | — |
Countries
France
Outcome results
None listed