E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis of influenza in healthy volunteers (6 months and older) |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of influenza in healthy volunteers (6 months and older) |
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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 | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
- To describe the safety of the Quadrivalent Influenza Vaccine (QIV). - Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.
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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 |
- Aged 6 months and older on the day of inclusion - Participants aged < 18 years: ICF has been signed and dated by the parent or another legally acceptable representative; Assent form has been signed and dated by the participant aged 12 to 15 years. - Participants aged ≥ 16 years: ICF signed and dated by the participant. - Participants are able to attend all scheduled visits and to comply with all study procedures. For participants aged 6 months to 17 years, parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures - For participants < 2 years: Born at full term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg |
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E.4 | Principal exclusion criteria |
- Participant is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a woman must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile - Participation at the time of study enrollment (or in the 4 weeks preceding study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, device, or medical procedure - Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination. - Receipt of immune globulins, blood or blood-derived products in the past 3 months - 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) - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances - Known thrombocytopenia, contraindicating intramuscular vaccination based on investigator’s judgment - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination based on investigator’s judgment - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol abuse or drug addiction - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness/body temperature (temperature ≥ 37.5°C or ≤ 35.5°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided - Identified as Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Occurrence of unsolicited systemic adverse events (AEs) reported in the 30 minutes following each and any vaccination. 2. Occurrence of solicited (prelisted in the subject diary and the electronic Case Report Form) injection site reactions and systemic reactions. 3. Occurrence of unsolicited (spontaneously reported) non-serious adverse events (AEs). 4. Occurrence of serious adverse events (SAEs), including adverse events of special interest (AESIs). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. During the 30 minutes following the vaccination 2. From D0 to D7 after the vaccination 3. From D0 to D28 after the vaccination 4. From D0 to the end of the study |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | No |
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 | 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 | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |