Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects - Open, phase II trial. 200 subjects aged 18 to 60 years will receive the non-adjuvanted vaccine

Phase 1

• Conditions: Preventive vaccination in healthy subjects aged 18 to 60 years against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1)

• Registration Number: EUCTR2010-018991-25-FR
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-16
• Study Completion: 2010-09-21
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 202

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified