E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Healthy Volunteers (influenza Vaccine) Influenza infection is a major cause of respiratory disease that affects all age groups, leading to significant morbidity and mortality. Complications of influenza include otitis media, pneumonia, exarcerbations of chronic respiratory disease and bionchiolitis (in children) but also nonrespiratory complications such as febrile convulsions or myocarditis |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of influenza disease irrespective of strains (seasonal and/or pandemic) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
Primary objective To evaluate the immunogenicity of one dose of OVX836 influenza vaccine at two dose levels (90 µg and 180 μg), in comparison to Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine, 7 days after intramuscular administration in healthy subjects aged 18-65 years
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E.2.2 | Secondary objectives of the trial |
Secondary objectives • To evaluate the safety and reactogenicity of all investigational vaccines in the study. • To evaluate the immune response to influenza virus NP between two dose levels (90 µg and 180 μg) of OVX836. • To evaluate the immune response to all the investigational vaccines in the study in two age strata: subjects aged 18 to 49 years and subjects aged 50 to 65 years.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria 1. Written informed consent. 2. Healthy male or female subjects, as determined by medical history and medical examination. 3. Between the ages of 18 and 65 years, inclusive. 4. Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.
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E.4 | Principal exclusion criteria |
Exclusion criteria 1. Subject with a body mass index (BMI) ≥35 kg/m² on the day of vaccination 2. Previous influenza vaccination within 6 months before the day of vaccination, or planned to receive during the study duration. 3. Any known or suspected immunodeficient conditions. 4. Past or current history of significant autoimmune diseases, as judged by the Investigator. 5. Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator. 6. Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group [CTFG] as follow: “Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse).” 7. Having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines. 8. Planning to receive other vaccines during the first 28 days following the study vaccine administration. 9. Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period. 10. History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period. 11. Presence of an acute febrile illness on the day of vaccination (oral temperature >38.0°C, temporary exclusion criterion). 12. Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome. 13. Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study. 14. Past (stopped less than 6 months before enrolment) or current history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day. 15. Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800 μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator. 16. Subjects with known or suspected anemia. 17. Recent blood or platelets donation (less than 3 months before enrolment). History of plasma donation is authorized. 18. History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin, or to any component that may be present in the comparator vaccine, as traces such as eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, or gentamicin. 19. Any contraindication to intramuscular administration, as judged by the Investigator. 20. Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study. 21. Technical difficulties in the use of an e-diary. 22. Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint • Cell-mediated immune response to the study vaccines in terms of change of NP-specific T-cell activity at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 8 versus pre-injection baseline (Day 1) in the pooled age strata.
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E.5.2 | Secondary end point(s) |
Secondary endpoints 1. Secondary safety endpoints: • Number and percentage of subjects reporting solicited local and systemic symptoms during 7 days after vaccine administration. • Number and percentage of subjects reporting unsolicited AEs during 28 days after vaccine administration. • Number and severity of ILI cases during the whole study duration. • Number and percentage of subjects reporting SAEs during the whole study duration.
2. Secondary immunogenicity endpoints: • Cell-mediated immune response to the study vaccines in terms of change of NP-specific T-cell activity at Day 8 versus pre-injection baseline (Day 1), analyzed separately in the two age strata. The following analyses will be performed in the pooled age strata and each age stratum considered separately: • Cell-mediated immune response to the study vaccines in terms of change of NP-specific T-cell activity at Day 29 and Day 180 versus pre-injection baseline (Day 1). • Mean NP-specific T-cell counts (ELISPOT on PBMCs) at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180. • Number and percentage of subjects with increase of total NP-specific T-cell counts with respect to pre-injection baseline (Day 1), at Day 8, Day 29 and Day 180. • NP T-cell phenotype (CD4+, CD8+) and functionality (IL-2, TNFα, IFNγ by flow cytometry (on PBMCs) at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180. • Geometric mean titers (GMTs) of anti-NP Immunoglobulin G (IgG) (ELISA, serum) at pre-injection baseline (Day 1), Day 8, Day 29 and Day 180. • Number and percentage of subjects with an increase in anti-NP Immunoglobulin G (IgG) (ELISA, serum) titer with respect to pre-injection baseline (Day 1), at Day 8, Day 29 and Day 180.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Information explained in E.5.2 |
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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 | Yes |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.3.1 | Comparator description |
Influvac TetraTM, quadrivalent seasonal influenza sub-unit vaccine |
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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
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |