Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly subjects - Immunogenicity and safety of different formulations of intramuscular swine-origin influenza vaccine
- Conditions
- Preventive vaccination in healthy subjects aged 18 years and over against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)
- Registration Number
- EUCTR2009-013344-37-FR
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 450
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
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method