E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of influenza infection in adults from 60 years of age and older |
|
E.1.1.1 | Medical condition in easily understood language |
Active immunisation of adults from 60 years of age and older against influenza
infection |
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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 |
|
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 demonstrate that QIV-HD induces an immune response that is superior to the responses induced by QIV-SD for all 4 virus strains 28 days post-vaccination in subjects 60 to 64 years of age and in subjects 65 years of age and older. |
|
E.2.2 | Secondary objectives of the trial |
To further describe the immune response induced by QIV-HD and QIV-SD in all subjects by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD).
To describe the safety profile of all subjects by age group, in pooled age groups, and by vaccine group (QIV-HD; QIV-SD). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Sixty years of age and older on the day of inclusion
- Able to attend all scheduled visits and to comply with all trial procedures |
|
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 female must be post-menopausal for at least 1 year, or surgically sterile
- Participation at the time of study enrollment (or in the 4 weeks [28 days] preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to V02
- Previous vaccination against influenza (in the previous 6 months) with either the trial vaccine or another vaccine
- 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 vaccines used in the trial or to a vaccine containing any of the same substances
- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) vaccination based on Investigator’s judgement
- Alcohol or substance abuse that, in the opinion of the Investigator might interfere with the trial conduct or completion
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to Investigator judgment) or febrile illness (temperature ≥ 38.0°C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
- Personal or family history of Guillain Barré syndrome (GBS)
- Neoplastic disease or any hematologic malignancy (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy and participants who have a history of neoplastic disease and have been disease free for ≥ 5 years) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Geometric Mean Titers (GMTs) of influenza vaccine antibodies (post-vaccination) : Antibody titers will be measured by hemagglutination inhibition (HAI) assay |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 28 (post-vaccination) |
|
E.5.2 | Secondary end point(s) |
- Geometric Mean Titers (GMTs) of influenza vaccine antibodies (pre- and post-vaccination) : Antibody titers will be measured by HAI assay
- Geometric Mean Titers Ratio (GMTR) of influenza vaccine antibodies (post-/pre-vaccination) : Antibody titers will be measured by HAI assay
- Percentage of participants with antibody titers ≥ 40 [1/dil] : Antibody titers will be measured by HAI assay
- Percentage of participants achieving serconversion : Influenza vaccine antigens will be measured by HAI assay
Seroconversion is defined as either a pre-vaccination titer lower than (<) 10 [1/dil] and a post-vaccination titer greater than or equal to (≥) 40 [1/dil], or a pre-vaccination titer ≥ 10 [1/dil] and a ≥ 4-fold increase in post-vaccination titer
- Percentage of participants reporting solicited injection site reactions and systemic reactions : Injection site reactions: pain, erythema, swelling, induration and ecchymosis
Systemic reactions: fever, headache, malaise, myalgia and shivering |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Geometric Mean Titers (GMTs) of influenza vaccine antibodies (pre- and post-vaccination) : Day 0 (pre-vaccination) and Day 28( post-vaccination)
- Geometric Mean Titers Ratio (GMTR) of influenza vaccine antibodies (post-/pre-vaccination) : Day 0 (pre-vaccination) and Day 28 (post-vaccination)
- Percentage of participants with antibody titers ≥ 40 [1/dil] : Day 28 (post-vaccination)
- Percentage of participants achieving serconversion : Day 28 (post-vaccination)
- Percentage of participants reporting solicited injection site reactions and systemic reactions : Within 7 days post-vaccination
|
|
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 | 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 |
|
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 | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
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
|
DAY 180 safety follow-up telephone call (approximately 6 months after vaccination). |
|
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 | |
E.8.9.2 | In all countries concerned by the trial months | 8 |