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 5 years to less than 9 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 |
To evaluate the frequency and intensity of fever in healthy pediatric subjects 5 to less than 9 years of age administered the 2014-2015 Northern Hemisphere season formulation of CSL TIV, in the 7 days after each administration. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the frequency and intensity of fever in healthy pediatric subjects 5 to less than 9 years of age administered the 2014-2015 Northern Hemisphere season formulation of the Comparator Quadrivalent Influenza Virus Vaccine (QIV), in the 7 days after each administration.
2. To further describe the nature of febrile events observed in healthy pediatric subjects after each administration of CSL TIV or the Comparator QIV.
3. To assess the safety and tolerability of CSL TIV in healthy pediatric subjects 5 to less than 9 years of age in the 7 days after each administration.
4. To assess the safety and tolerability of the Comparator QIV in healthy pediatric subjects 5 to less than 9 years of age in the 7 days after each administration. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
* Males or females aged 5 to less than 9 years at the time of first study vaccination. * The subject’s parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements. * In good health, as determined by medical history and a targeted physical examination (if warranted).
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E.4 | Principal exclusion criteria |
* Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines. * Clinical signs of significant active infection or an elevated oral temperature at study entry. * A clinically significant medical or psychiatric condition. * A history of seizures or febrile convulsions or Guillain-Barré syndrome. * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation. * Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry. * Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine. * Currently receiving treatment with warfarin or other anticoagulants. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The frequency and intensity of fever events occurring during the 7 days after each administration of CSL TIV vaccine. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately 7 days after each vaccination. |
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E.5.2 | Secondary end point(s) |
The frequency and intensity of fever events occurring during the 7 days after each administration of the comparator influenza virus vaccine.
The frequency and intensity of vaccine-related fever events occurring during the 7 days after each administration of CSL TIV vaccine or comparator influenza virus vaccine.
The frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
The frequency of solicited systemic AEs occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
The frequency of unsolicited AEs occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine.
The incidence of Serious Adverse Events (SAEs) occurring up to 7 days after the last administration of CSL TIV or the comparator influenza virus vaccine. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Approximately 7 days after each 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 | No |
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 | 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 months | 4 |