| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (Immunization against influenza in male and female subjects 3 to 8 years of age inclusive) |
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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.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
•To evaluate the efficacy of Q-QIV in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed influenza A and or B disease presenting as influenza like illness (ILI), compared to a non-influenza vaccine comparator (Havrix) in children 3 to 8 years of age.
Influenza-like illness (ILI) was defined as the presence of an oral or axillary temperature ≥37.8° C in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion
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| E.2.2 | Secondary objectives of the trial |
•To evaluate the efficacy of Q-QIV in the prevention of moderate to severe cases of influenza confirmed by RT-PCR, compared to Havrix.
•To evaluate the efficacy of Q-QIV (when compared to Havrix) in the prevention of culture-confirmed influenza A and/or B disease due to seasonal influenza strains anti-genically matching the vaccine strains.
•To describe the immunogenicity (geometric mean titer, seroconversion rate, seroconversion factor and seroprotection rate) of Q-QIV 28 days after completion of vaccination in a subset of subjects.
•To assess the reactogenicity/safety of Q-QIV in terms of:
-Solicited local and general symptoms during 7 days of follow-up (day of vaccination and 6 sub-sequent days) after each vaccination
-Unsolicited symptoms during 28 days of follow-up (day of vaccination and 27 subsequent days) after each vaccination
-Serious adverse events , medically attended adverse events and potential immune-mediated diseases throughout the entire study period
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Subjects who the investigator believed that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) could and would comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits, respects intervals between study visits).
•A male or female child aged between 3 years and 8 years inclusive (i.e., not having attained the 9th birthday) at the time of the first vaccination; children were eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who had received any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine would not be enrolled.
•Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
•Written assent obtained from the subject if/as required by local regulations.
•Subjects in stable health as determined by investigator’s clinical examination and assessment of subjects’ medical history.
•Access to a consistent means of telephone contact
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| E.4 | Principal exclusion criteria |
•Child in care (i.e., a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian)
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. Routine registered childhood vaccinations were permitted.
•Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period.
•Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at ≥12 months of age.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this was a dose equivalent to either > 2 mg/kg of body weight or maximum of 20 mg/day of pred-nisone or equivalent when administered for > 2 weeks. Inhaled and topical steroids were allowed.
•Administration of immunoglobulins and/or any blood prod-ucts within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
•History of Guillain-Barré syndrome within 6 weeks of receipt of prior influenza vaccine.
•Any known or suspected allergy to any constituent of in-fluenza vaccines (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
•Fever (temperature >= 38.0°C or 100.4°F by any method) at the time of enrolment.
•Acute disease (moderate or severe illness) at the time of enrolment.
•Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
•Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
•Ongoing aspirin therapy (to avoid potential cases of Reye’s syndrome).
•Any other condition which, in the opinion of the Investigator, prevented the subject from participating in the study
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| RT-PCR-confirmed influenza A and/or B disease. The primary endpoint required a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with ILI (influenza like illness) |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| First occurrence of outcome |
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| E.5.2 | Secondary end point(s) |
A. RT-PCR confirmed moderate to severe influenza A and/or B during the influenza surveillance period.
Moderate to severe influenza defined as RT-PCR-confirmed ILI (influenza like illness) with:
-Fever >39 degree Celsius (39°C), and/or at least one of the following manifestations,
-Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following,
-Physician-diagnosed serious extra-pulmonary com-plication of influenza, including myositis, encephalitis, seizure, or myocarditis
B. Culture-confirmed influenza A and/or B disease (as defined in the primary outcome/efficacy variable) antigenically-matching with the influenza strains, during the influenza surveillance period
C. Culture-confirmed influenza A and/or B disease (as defined in the primary outcome/efficacy variable) due to any influenza strains, during the influenza surveillance period
D. Occurrence, intensity, and relationship to vaccination of solicited local and general adverse events AE(s)
E. Occurrence, intensity and relationship to vaccination of unsolic-ited AE(s)
F. Occurrence and relationship to vaccination of serious adverse events (SAEs), medically attended adverse events (MAEs), and potential immune-mediated diseases (pIMDs) |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
First occurrence of outcome (for A, B, and C)
During a 7-day follow-up period after each vaccination (for D)
During a 28 day follow-up period after each vaccination (for E)
During the entire study (for F) |
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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 | No |
| 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 | 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 |
| Bangladesh |
| Dominican Republic |
| Honduras |
| Lebanon |
| Panama |
| Philippines |
| Thailand |
| Turkey |
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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 | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 0 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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