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 | 18.0 |
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: To evaluate the antibody responses to homologous
(CBER criteria) influenza strains post vaccination with aQIV or a non-adjuvanted
comparator influenza vaccine in children previously vaccinated in parent trial V118_05.
Primary Safety Objective: To evaluate the safety of revaccination of aQIV or nonadjuvanted
comparator vaccine in children previously vaccinated in parent trial V118_05 |
|
E.2.2 | Secondary objectives of the trial |
Secondary Immunogenicity Objective:
To evaluate the antibody responses to heterologous influenza strains post vaccination with
aQIV or a non-adjuvanted comparator influenza vaccine in children previously vaccinated
in parent trial V118_05. Moreover, the comparison of the two treatment groups regarding
the immunogenicity variables will be carried out. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to participate in this study, all subjects must meet ALL of the inclusion criteria
described.
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 Day 181 clinic visit for non-naïve
subjects or their Day 209 clinic visit for naïve subjects in parent study V118_05.
3. Subject whose treatment assignment in study V118_05 has remained blinded.
4. 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 the non-adjuvanted comparator). |
|
E.4 | Principal exclusion criteria |
In order to participate in this study, all subjects must meet NONE of the exclusion criteria
described:
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 Folder).
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 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 are 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 study through the duration of this trial. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary safety endpoint: Percentage of subjects reporting SAEs, AEs leading to withdrawal from the study,
NOCDs, AESI and concomitant medications associated with these events as collected
from Day 1 through the Study Termination Visit.
Primary immunogenicity endpoint:
The following primary immunogenicity endpoints will examined for the homologous
strains for all cohorts at Days 1 and 22:
- Percentage of subjects achieving seroconversion.
- Percentage of subjects achieving HI titer >1:40. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 1 through Study Termination Visit. |
|
E.5.2 | Secondary end point(s) |
The secondary measures for assessing safety and tolerability are as follows:
- Percentage of subjects with solicited local and systemic AEs and other solicited
data as measured for 7 days following vaccination.
- Percentage of subjects with any unsolicited AEs reported will be assessed from
Day 1 through Day 22.
- Percentage of children with a diagnosis of failure to thrive or short stature
collected from Day 1 through the Study Termination Visit. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 1 through 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 | 2 |
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 | No |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |