E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis for influenza virus infection |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 19.0 |
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 demonstrate that vaccination with Seqirus QIV elicits an immune response that is not inferior to that of a US licensed comparator QIV containing the same virus strains as Seqirus QIV, among a pediatric population 5 through 17 years of age. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are to assess the following: 1. To assess safety and tolerability of Seqirus QIV, among children 5 through 17 years of age in two age strata: 5 through 8 years of age, and 9 through 17 years of age, as well as overall. 2. To characterize the immunogenicity of Seqirus QIV and the US-licensed comparator QIV in two age strata: 5 through 8 years of age, and 9 through 17 years of age, as well as overall. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Males or females 5 through 17 years of age on the day of first study vaccination. * Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws. Participant assent will also be obtained if required. * If applicable, females of “childbearing potential” (ie, ovulating, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen until at least 28 days after the last Study Vaccine. Females of childbearing potential must return a negative urine pregnancy test result, prior to any vaccination dose with the Study Vaccine. |
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E.4 | Principal exclusion criteria |
* History of allergic reactions to egg proteins or any components of the Study Vaccines. * History of serious adverse reactions to any influenza vaccines. * History of Guillain-Barré syndrome or other demyelinating disease. * History of licensed or investigational influenza vaccination in the last 6 months. * Clinical signs of active infection and/or an oral temperature of ≥ 100°F (37.8°C) on the day of planned Study Vaccine administration or within 48 hours preceding vaccination. * Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable (such as illness exacerbations) within the preceding 30 days. * History of any seizures, with the exception of a single febrile seizure. * Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C. * Known or suspected congenital or acquired immunosuppressive conditions. * Current or recent immunosuppressive or immunomodulatory therapy, as follows: * Chronic or long-term systemic corticosteroids: ≥ 0.125 mg/kg/day of oral prednisolone or equivalent daily; * Sporadic systemic corticosteroids: ≥ 0.5 mg/kg/day of oral prednisolone or equivalent for two or more short courses of > 3 days in the 3 months preceding vaccination; * Antineoplastic chemotherapy or radiation therapy within the 6 months preceding vaccination. Note: Use of topical, inhalant or localised tissue injections of corticosteroids prior to administration of the Study Vaccine or throughout the study are acceptable. * Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or planned administration during the study. * Participation in a clinical trial or use of an investigational compound within 28 days prior to the first dose of Study Vaccine, or within 28 days after receiving the final indicated dose of Study Vaccine, or plans to enter a study during this period. * Vaccination with a licensed vaccine 28 days (for live or inactivated vaccines) prior to receiving the first dose of Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit. * Pregnant or lactating females. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. The Geometric Mean Titre (GMT) ratio of each virus strain 2. The difference in Seroconversion Rate (SCR) for each virus strain
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 28 days after last vaccination 2. 28 days after last vaccination
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E.5.2 | Secondary end point(s) |
1. Safety Endpoint: The frequency and severity of solicited local adverse reactions 2. Safety Endpoint: The frequency and severity of solicited systemic adverse events (AEs) 3. Safety Endpoint: The frequency of cellulitis-like reaction 4. Safety Endpoint: The frequency and severity of unsolicited adverse events (AEs) 5. Safety Endpoint: The frequency of serious adverse events (SAEs) 6. Immunogenicity Endpoint: GMTs - Geometric mean of HI titers prevaccination (Day 1) and postvaccination (Study Exit Visit) 7. Immunogenicity Endpoint: Seroconversion rate 8. Immunogenicity Endpoint: Seroprotection rate 9. Immunogenicity Endpoint: Geometric mean fold increase
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 7 days after each vaccination 2. 7 days after each vaccination 3. 28 days after each vaccination 4. 28 days after each vaccination 5. 180 days after the last vaccination dose 6. 28 days after last vaccination 7. 28 days after last vaccination 8. 28 days after last vaccination 9. 28 days after last vaccination |
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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 | 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) | 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 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
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 | Yes |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |