E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Preventive vaccination in healthy subjects aged 18 to 60 years against infection with S-OIV (Swine Origin Influenza Virus) A/California/7/2009 (H1N1) |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To describe the immune response of the inactivated, split-virion swine-origin A/H1N1influenza vaccine without adjuvant in each group
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
Same product but 0.5mL administered according to the approved SmPC |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is the last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |