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 |
Active immunisation against influenza infection in children aged 6 months to less than 18 years. |
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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 |
Safety and tolerability of CSL Limited’s Influenza Virus Vaccine (CSL’s IVV) in a pediatric population aged 6 months to less than 18 years. |
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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 |
Healthy children were eligible for enrollment if they were aged 6 months to less than 18 years and were born at or after 36 weeks gestation (this criterion applied only to participants aged younger than 9 years) or returned a negative pregnancy test (this criterion applied only to female participants aged 9 years or older). |
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E.4 | Principal exclusion criteria |
An allergy to any vaccine components; evidence of an active infection; receipt of an experimental or seasonal influenza vaccine in the previous 6 months; a confirmed or suspected immunosuppressive condition; a history of Guillain-Barré Syndrome; a major congenital defect or serious illness; a history of neurologic disorders or seizures; administration of immunoglobulins or any blood products; participation in a clinical study or use of an investigational compound; immunosuppressive or immunomodulatory medication, including systemic corticosteroids; and treatment with cytotoxic drugs.
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency, severity and duration of local and systemic Solicited adverse events (AEs) for 6 days (total 7 days) following any study vaccination in each age cohort.
Frequency, severity and duration of Unsolicited AEs for 29 days (total 30 days) following any study vaccination in each age cohort.
Frequency, severity and duration of Serious adverse events (SAEs) and New onset of chronic illness (NOCI) for 180 days following any study vaccination in each age cohort. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
7, 30, 180 days after any study vaccination. |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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.8.2.4 | Number of treatment arms in the trial | 3 |
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 months | 8 |