| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Prophylaxis for influenza virus |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| 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 |
|
| 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 |
Primary Immunogenicity Objective(s)
- To demonstrate non-inferiority of Haemagglutination Inhibition (HI) antibody responses to aQIV vs QIV vaccine against each of the 4 homologous strains in terms of Geometric Mean Titer ratio (GMT-ratio) 21 days after vaccination in children who have previously received vaccination with aQIV in parent trial V118_05 (A vs. B in Table 1.2-1).
Once the above primary objective is successfully tested the following primary objective will be tested.
- To demonstrate superiority of HI antibody responses to aQIV vs QIV vaccine for at least two out of four homologous strains in terms of GMT-ratio 21 days after vaccination in children who have previously received vaccination with aQIV in parent trial V118_05 (treatment arms A vs B, Table 1.2-1)
|
|
| E.2.2 | Secondary objectives of the trial |
Secondary Immunogenicity Objective(s)
-To assess the non-inferiority and superiority of HI antibody responses to aQIV vs QIV vaccine against each of the 4 homologous strains in terms of differences in the proportion of subjects with seroconversion (SC) 21 days after vaccination in children who have previously received vaccination with aQIV in parent trial V118_05 (treatment arms A vs B, Table 1.2-1).
-To assess the non-inferiority and superiority of HI antibody responses to aQIV vs QIV vaccine against each of the 4 homologous strains in terms of GMT-ratio at Day 181 in children who have previously received vaccination with aQIV in parent trial V118_05 (treatment arms A vs B);
Secondary Safety Objectives:
-To evaluate the safety of revaccination of aQIV or QIV comparator influenza vaccine in children previously vaccinated in trial V118_05.
For complete list of secondary objectives please refer to protocol sections 2.2 and 2.3. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Subject’s parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
2. Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
3. For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV). |
|
| E.4 | Principal exclusion criteria |
1. Progressive, unstable or uncontrolled clinical conditions or any fatal condition (<12 month life expectancy).
2. History of epilepsy or convulsions (excluding febrile convulsions).
3. A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see Investigator Study File).
4. Individuals who have been diagnosed with any disorders in growth such as failure to thrive or short stature.
5. Subjects hospitalized at the time of enrollment.
6. Subjects with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component, to eggs (including ovalbumin), and
chicken protein, latex.
7. Subjects who have received antipyretic medication within the past 24 hours prior to vaccination. The subject may return for vaccination after a period of 24 hours has passed since the administration of an antipyretic.
8. Subjects who have had a fever [body temperature measurement ≥ 38°C (≥ 100.4°F)] within three consecutive days prior to vaccination. The subject may return for vaccination after they have been free of fever for three days.
9. Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
10. Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
11. Subjects who are children of research staff directly involved with the clinical study or who are otherwise related to research staff or have household members who are research staff. Research staff is individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.
12. Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary immunogenicity endpoint will be the Geometric Mean Titer (GMT) for the homologous strains for groups A vs. B at Visit 2 (Day 22±7). |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Immunogenicity endpoint: Visit 2 (Day 22±7). |
|
| E.5.2 | Secondary end point(s) |
Secondary immunogenicity endpoints will include the following:
Homologous strains, all treatment groups:
- The percentage of subjects achieving, HI antibody titer ≥ 1:110, 151, 215, 330, 629 at Days 22.
Homologous and heterologous strains, all treatment groups (subset of subjects for analysis of heterologous strains):
- Percentage of subjects achieving SC (Day 22);
- GMT (Days 22 and 181);
- GMR (Day 22:Day 1; Day 181:Day 1);
- The percentage of subjects achieving HI titer ≥ 1:40 (Day 22, 181).
The measures for assessing safety and tolerability are as follows:
- Percentage of subjects reporting SAEs, AEs leading to withdrawal from the study, NOCDs, AESIs, medically attended AEs and concomitant medications associated with these events as collected from Day 1 through the Study Termination Visit.
- Percentage of subjects with solicited local and systemic AEs and other solicited data as measured for 6 days following vaccination.
- Percentage of subjects with any unsolicited AEs reported will be assessed from Day 1 through Day 22.
- Percentage of subjects with a diagnosis of failure to thrive or short stature as collected from Day 1 through the Study Termination Visit. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity endpoints: Days 1, 22, and 181.
Safety endpoints: Day 1 through the Study Termination Visit. |
|
| 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 |
|
| 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 | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| 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 | 4 |
| 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 | 9 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 9 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
| Philippines |
| Thailand |
| United States |
|
| 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
|
| End of study is defined as the completion of the testing of such biological samples, to be achieved no later than 8 months after collection of the last biological sample at Visit 7 (Day 181) or after the completion of the Last Subject Last Visit (LSLV), whichever is the latest. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 0 |
| E.8.9.1 | In the Member State concerned days | 0 |
| 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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