E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
vaccine against influenza |
|
E.1.1.1 | Medical condition in easily understood language |
vaccine against influenza |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016794 |
E.1.2 | Term | Flu vaccination |
E.1.2 | System Organ Class | 100000004865 |
|
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 investigate the immunogenicity and safety of M-001 in a prime-boost strategy with H5N1 vaccination in healthy adults. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the humoral immune responses (serum hemagglutination inhibition (HAI) titer) in all groups 0 and 63 days following M-001 and H5N1 vaccination in all subjects towards the H5N1 vaccine strain. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Healthy male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 60 years, inclusive;
-Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate contraception (a combination of barrier and hormone methods for women and a condom for men) throughout the study treatment and for at least up to day 51 (for female) and day 111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the last dose of the IMP)
-Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), medical history, general physical examination, self-reported illness and clinical judgment of the investigator
-Able to understand and comply with planned study procedures
-Provides signed informed consent form after receiving a detailed explanation of the study protocol prior to any study procedures.
|
|
E.4 | Principal exclusion criteria |
-Has a known allergy to components of the vaccine (e.g. egg products)
-Has a history of severe reactions following immunization with contemporary influenza virus vaccines
-Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy
-Has a positive urine pregnancy test prior to vaccination or women who are breastfeeding
-Has a history of any of the following (reported by subjects):
Acute disseminated encephalomyelitis (ADEM);
Active neoplastic disease;
Asthma or severe allergic disease;
Bleeding disorders
Chronic Hepatitis B and/or C infection;
Chronic liver disease;
Diabetes mellitus;
Guillain-Barré syndrome;
HIV;
Rheumatoid arthritis or other autoimmune diseases;
Severe renal disease;
Transplant recipients;
Unstable or progressive neurological disorders.
Receipt of medicines/treatments that may affect evaluation of immunogenicity such as:
Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs;
Immunoglobulin or other blood products (within the 3 months prior to vaccination in this study);
Experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent (during the 18-month study period).
Influenza antiviral medication (within the 4 weeks prior to vaccination in this study).
-Has received any influenza vaccine within 6 months prior to vaccination in this study.
-Has influenza-like illness within 6 months prior to vaccination in this study.
-Has an acute illness, including an oral temperature greater than 38 degrees oC, within 1 week before vaccination
-Has a history of alcohol or drug abuse
-Any abnormal hematology values and/or serum chemistries judged by the Investigator as clinically significant
-Ineligible subject based on the judgement of the investigator
-In case there is uncertainty about the participant’s medical status regarding any of the exclusion criteria mentioned, the participant’s primary care physician will be consulted. Consultation of the primary care physician will only take place after having received written approval from the participant, and will concern medical information about exclusion criteria only
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
For immunogenicity: To evaluate the cellular immune responses based on multiparametric FACS analysis in all groups at 0 and 42 days following M-001 vaccination, in all subjects. For safety: (1) To evaluate the solicited AEs in all subjects until 21 days after the last dosing of the study vaccine (M-001); (2) To evaluate the unsolicited AEs and SAEs in all subjects for 180 days after the first dosing of M-001. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
180 days after the first dosing of M-001 |
|
E.5.2 | Secondary end point(s) |
To evaluate the humoral immune responses (serum hemagglutination inhibition (HAI) titer) in all groups at 0 and 63 days following M-001 and H5N1 vaccination in all subjects towards the H5N1 study vaccine strain. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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 |
|
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
testproducts and placebo are followed by an administration of AlPO4-adjuvanted H5N1 monov pand vacc. |
|
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.8.2.4 | Number of treatment arms in the trial | 3 |
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 | No |
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
|
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | |