E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of 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 | 18.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10022005 |
E.1.2 | Term | Influenza viral infections |
E.1.2 | System Organ Class | 100000004862 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062297 |
E.1.2 | Term | Immunology test |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065109 |
E.1.2 | Term | Reactogenicity event |
E.1.2 | System Organ Class | 10018065 - General disorders and administration site conditions |
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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 demonstrate in subjects ≥ 18 years of age the non-inferiority of QIV with respect to post-vaccination geometric mean hemagglutinin inhibition (HI) antibody titers against the shared strains compared with the trivalent influenza vaccines (TIV) with either the B-strain of the Victoria (TIV(Vic)) or the B-strain of the Yamagata lineage (TIV(Yam)). |
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E.2.2 | Secondary objectives of the trial |
To demonstrate in subjects ≥ 18 years of age the superiority of QIV to TIV(Vic) and TIV(Yam) with respect to post-vaccination geometric mean hemagglutinin inhibition (HI) antibody titers against the alternate-lineage B strain.
To describe the immunogenicity with respect to HI and virus neutralization (VN) antibody titers using the derived serology parameters seroconversion and geometric mean fold increase for each of the strains in QIV and TIV, in adults (≥ 18 to ≤ 60 years of age) and elderly (≥ 61 years of age).
To describe the immunogenicity with respect to HI and VN antibody titers in study population subsets according to age and pre-existing antibody status for each of the strains in QIV and TIV.
To describe cell-mediated immunity values for a subset of subjects.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.
2. Men and women aged ≥ 18 years of age at the day of study vaccination.
3. Being in good health as judged by medical history, physical examination and clinical judgment of the Investigator (subjects may have underlying chronic illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as their symptoms/signs are controlled. If on regular prescribed medication for a condition, the medication dose must have been stable for at least three months preceding study vaccination).
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E.4 | Principal exclusion criteria |
1. History of allergy to egg, chicken proteins, or other vaccine components.
2. History of serious adverse reaction to any influenza vaccine.
3. History of Guillain-Barré syndrome.
4. Confirmed influenza infection or vaccination against influenza in the 6 months preceding enrollment.
5. Receipt of any vaccine within the preceding 4 weeks prior to study vaccination or planned vaccination during the study between Visit 1 (Day 1) and Visit 2 (Day 22).
6. Having fever and/or presenting with an acute disease or infection on the day of study vaccination. Fever is defined as an oral temperature of ≥ 38.0 ºC.
7. Any known immunocompromising condition or immunosuppressive therapy within 6 months preceding study vaccination.
8. Using or having used medication that influences the immune system (such as corticosteroids and monoclonal antibodies) during the four weeks prior to the study or planned use thereof during the study. Topical use of corticosteroids (i.e., cream, ocular drops, inhalation and intranasal sprays), within the dosage noted on the product label, is allowed.
9. Receipt of blood or blood products within the 3 months preceding enrollment.
10. Participation in a placebo-controlled influenza vaccine clinical trial any time prior to entering this study if the treatment arm is not known.
11. Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the study vaccine including (but not limited to) bleeding disorder, known immunodeficiency, seizure disorder, acute, severe or progressive hepatic, renal, neurological or neuromuscular disease.
12. Being a solid organ or bone marrow/stem cell transplant recipient.
13. Use of cytotoxic drugs, anticancer chemotherapy or radiation therapy within 36 months before the day of study vaccination. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Non-inferiority will be inspected by calculating for each of the two A-strains and each of the two B-strains a two-sided 95% confidence interval for geometric mean ratios (GMRs) for the contrast TIV versus QIV, using an analysis of variance model for the log-transformed titers |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Visit 2 (Day 22 -2/+4 days) |
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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 |
At each visit or phone contact |
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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 | 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 |
Immunogenicity and reactogenicity |
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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) | 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 | 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.8.2.4 | Number of treatment arms in the trial | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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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Last Subject Last Visit (Phone contact 2, Day 183). |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |