E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis of Influenza A (H1N1) infection. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
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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 |
The primary objective of the study is to assess the efficacy of the influenza vaccine GHB11L1 against an influenza virus challenge in comparison to a placebo control group. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess safety and tolerability, local and systemic immune response and pharmacokinetics (vaccine virus shedding) of GHB11L1. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male subjects aged 18 to 45 years. 2. In general good health determined by a screening evaluation ≤45 days prior to double-blind IMP administration and on the day of double-blind IMP administration 3. Males should be willing to use a reliable form of contraception approved by the Investigator (use of a condom plus spermicide, or a female partner fulfilling the following criteria: hysterectomy or bilateral tubal ligation, oral or implanted contraceptive use, intrauterine device or barrier method plus spermicide) from immunisation phase baseline (Day -28±2) until 28 (±2) days after the influenza challenge 4. Negative human immunodeficiency virus (HIV), hepatitis B and C antibody screen 5. Negative drugs of abuse, alcohol and nicotine screen 6. Seronegative for influenza A/Brisbane/59/07(H1N1) (antibody titres <1:10 detected in HAI assay). 7. Have not been vaccinated for influenza virus in 2006/2007 and/or later seasons or had a known influenza infection in the current or latest season. 8. Give written informed consent to participate after reading the Consent Form and after having adequate opportunity to discuss the study with an Investigator or qualified deputy. 9. Willing and able to communicate with the Investigator and understand the requirements of the study, including willingness to enter and remain in quarantine until free of influenza infection. |
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E.4 | Principal exclusion criteria |
A complete list of exclusion criteria is given in the respective clinical study protocol:
1. Presence or evidence of significant acute or chronic, uncontrolled medical or psychiatric illness (subjects with uncomplicated chronic diagnoses stable and treated for ≥3 months e.g. mild hypertension well-controlled with medication, may be enrolled – provided the condition and its therapy are known not to be associated with an immunocompromised state or increased risks of complications of influenza) 2. Health care workers (including doctors, nurses, medical students and allied healthcare professionals) anticipated to have patient contact within two weeks of viral challenge. Healthcare workers who volunteer should not work with patients until 14 days after challenge or until their symptoms are fully resolved (whichever is the longer). In particular, any health care workers who work in units housing severely immunocompromised patients (e.g. bone marrow transplant units). 3. Presence of household member or close contact (for an additional two weeks after discharge from the isolation facility) who is: less than 3 years of age; has any known immunodeficiency; is receiving immunosuppressant medications; is undergoing or soon to undergo cancer chemotherapy within 28 days of challenge; diagnosed with emphysema or COPD; elderly residing in a nursing home, suffering from severe lung disease or medical condition including but not exclusive to the conditions listed in Section 18.4; or a transplant (bone marrow or solid organ) organ recipient 4. Any laboratory test which is abnormal and which is deemed by the Investigator(s) to be clinically significant, including blood chemistry, haematology or urinalysis. 5. Venous access inadequate for phlebotomy demands of the study 6. Clinically significant abnormality on ECG 7. Any history during adulthood of asthma, chronic obstructive pulmonary disease (COPD) or any chronic lung condition of any aetiology 8. Smokers who have smoked at any time in the three months prior to study entry or have a significant history of any tobacco/cannabis use at any time (tobacco: 10 pack year history = one box a day for 10 years) 9. Any anatomic or neurologic abnormality impairing the gag reflex or associated with a risk of aspiration, or history suggestive of such a problem, or any clinically relevant abnormal paranasal anatomy 10. Subject is type I or II diabetic 11. History or evidence of autoimmune disease or known impaired immune responsiveness (of any cause) 12. Receipt of systemic glucocorticoids (in a dose ≥5 mg prednisone daily or equivalent),antiviral drugs, immunoglobulins (Igs) or blood transfusions within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months 13. Presence of any febrile illness or symptoms of upper or lower tract respiratory infection on the day of double-blind IMP administration (such subjects may be reevaluated for enrolment after resolution of the illness). On Day 0, before challenge, symptoms of grade 1, “mild”, are acceptable 14. Presence of any febrile illness or symptoms of upper viral respiratory infection: • Existing on the day of challenge or between admission for Influenza challenge and administration of the challenge inoculum. Such subjects may be re-evaluated for enrolment after resolution of the illness • Within 2 weeks prior to challenge or if challenge is set to occur during November, December, January, February, or March if there are any symptoms suggestive of viral respiratory infection occurring between screening and challenge. 15. Known increased tendency of epistaxis (nose bleeds) 16. Rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to double-blind IMP administration 17. Known IgA deficiency, immotile cilia syndrome, or Kartagener’s syndrome 18. History of seasonal hay fever or a seasonal allergic rhinitis (SAR), including the use of symptomatic prescription only medication and non prescription medication. 19. Chronic use (more than once a week in any 2 of the 4 weeks preceding double-blind IMP administration) of any medication or other product (prescription or over-the counter (OTC)), for symptoms of rhinitis or nasal congestion or any chronic nasopharyngeal complaint, or chronic use of any IN medication for any indication. 20. Acute use of any medication or other product, prescription or over-the-counter for symptoms of rhinitis or nasal congestion within 7 days prior to double-blind IMP administration. This includes any corticosteroid or beta agonist containing nasal spray. 21. Receipt of blood products 8 weeks before study entry
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the efficacy of the vaccine in reduction of viral load of the challenge virus (challenge virus shedding) as determined by analysis of the TCID50 using area under the curve (AUC) measurements. |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |