E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female subjects aged 18 to 60 years. |
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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 assess the haemagglutination-inhibition (HI) immune response to the vaccine-homologous virus induced by vaccination with two doses of the H1N1 candidate vaccine (A/California/7/2009 [H1N1]v-like) containing 3.75 micro g of HA with AS03A or without AS03A in terms of European Medicines Agency (EMEA) (CHMP) guidance targets for pandemic vaccine seroconversion rate (SCR), seroprotection rate (SPR), and geometric mean fold rise (GMFR) at 21 days after the first dose of H1N1 vaccine in adults 18 to 60 years of age. |
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E.2.2 | Secondary objectives of the trial |
To describe (based on point estimates and 95% confidence intervals) immunogenicity to vaccine-homologous A/California/7/2009 (H1N1)v-like antigen (both groups) in terms of HI on D0, 21, 42, 182, and 364 in adults 18 to 60 yrs and in each age stratum (18-40 yrs, 41-60 yrs and within the 41-50 yrs and 51-60 yrs substrata). To describe (based on point estimates and 95% CIs) immunogenicity to A/California/7/2009 (H1N1)v-like antigen (both groups) on D0, 21, 42, 182, and 364 based on neutralising antibodies in adults 18 to 60 yrs and in each of the age strata (18-40 yrs, 41-60 yrs and within the 41-50 yrs and 51-60 yrs substrata), in a subset of half of the subjects. To describe the safety of each of the study vaccines in terms of solicited adverse events seven days post-vaccination, unsolicited AEs 21 days post Dose 1 and 63 days post Dose 2, adverse events of specific interest for the entire study period, and serious adverse events for the entire study period in both treatment groups. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- A male or female aged 18 to 60 years at the time of the first vaccination. - Subjects who the investigator believes that they can and will comply with the requirements of the protocol. - Written informed consent obtained from the subject. - Satisfactory baseline medical assessment by history and physical examination (stable health status with no exclusionary medical or psychiatric conditions). Stable health status is defined as the absence of health event satisfying the definition of an SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment. - Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device. - Female subjects of non-childbearing potential may be enrolled in the study.Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. - Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series. |
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E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator’s judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial. •Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports. •Presence of an axillary temperature ≥ 37.5°C, or acute symptoms greater than “mild” severity on the scheduled date of first vaccination. •Diagnosed with cancer, or treatment for cancer, within the past three years. -Persons with a history of cancer who are disease-free without treatment for three years or more are eligible. -Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excisions only are excepted and may enrol within three years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above. -Women who are disease free three years or more after the treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol. •Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection. •Clinically or virologically confirmed influenza infection within six months preceding the study start. •Chronic administration of immunosuppressants or other immune modifying drugs within six months of study enrolment or planned administration during the study period. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for persons for > two weeks. Inhaled and topical steroids are allowed. •Receipt of any immunoglobulins and/or any blood products within three months of study enrolment or planned administration of any of these products during the study period. •Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible. •An acute evolving neurological disorder or history of Guillain-Barré syndrome. •Administration of any vaccines within 30 days before vaccination. •Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions. •Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Humoral immune response in terms of Haemagglutination Inhibition (HI) antibodies in subjects from each vaccine group against A/California/7/2009 (H1N1)v-like virus: -SCR at 21 days after the first dose of H1N1 study vaccine (Day 21); -SPR at 21 days after the first dose of H1N1 study vaccine (Day 21); -GMFR at 21 days after the first dose of H1N1 study vaccine (Day 21).
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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 | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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Last subject last visit (LSLV) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |