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 |
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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 |
1) To demonstrate the non-inferiority in terms of seroprotection rate of AVAXIM 80U Pediatric vaccine versus HAVRIX 720 vaccine 1 month after booster vaccination. |
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E.2.2 | Secondary objectives of the trial |
1) To describe the immunogenicity of the study vaccines after booster vaccination in both vaccine groups.
2) To describe the safety after each injection of the study vaccines. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria to be checked at the screening visit (SC):
1) Toddlers, children and adolescents:
Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
Sub-Group 2: from 4 to 6 years of age on the day of inclusion
Sub-Group 3: from 7 to 9 years of age on the day of inclusion
Sub-Group 4: from 10 to 12 years of age on the day of inclusion
Sub-Group 5: from 13 to 15 years of age on the day of inclusion
2) Screening informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
Inclusion criteria to be checked at the inclusion visit (V01):
1) Toddlers, children and adolescents:
Sub-Group 1: from 12 months to 3 years of age on the day of inclusion
Sub-Group 2: from 4 to 6 years of age on the day of inclusion
Sub-Group 3: from 7 to 9 years of age on the day of inclusion
Sub-Group 4: from 10 to 12 years of age on the day of inclusion
Sub-Group 5: from 13 to 15 years of age on the day of inclusion
2) Inclusion informed consent form signed by the parent(s) or other legal representative for all the subjects and by the adolescents (sub-group 5 only)
3) Able to attend all scheduled visits and to comply with all trial procedures
4) Subject anti-HAV seronegative (IgG) according to the screening results (assay performed with local kit)
5) Subject HBsAg seronegative and ALT <40 IU/l according to the screening results |
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E.4 | Principal exclusion criteria |
Exclusion criteria to be checked at the inclusion visit (V01):
1) Participation in another clinical trial in the 4 weeks preceding trial vaccination
2) Planned participation in another clinical trial during the present trial period
3) Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
4) Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances
5) Chronic illness at a stage that could interfere with trial conduct or completion
6) Blood or blood-derived products received in the past 3 months
7) Any vaccination in the 4 weeks preceding the trial vaccination
8) Any vaccination planned in the 4 weeks following the trial vaccination
9) History of hepatitis A infection (confirmed either clinically or serologically )
10) Previous vaccination against hepatitis A with the trial vaccine or another hepatitis A vaccine
11) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
12) History of /current seizures
13) Clinical or serological evidence of systemic illness including Hepatitis C and HIV
14) Febrile (axillary temperature ≥ 37.1°C) or acute illness |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) To provide information concerning the immunogenicity of AVAXIM 80U Pediatric vaccine |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Immunogenicity:
1) Individual anti-Hepatitis A antibody titers
Safety:
1) The occurrence, nature (MedDRA preferred term), time to onset, duration, severity, relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination.
2) The occurrence, time to onset, number of days of occurrence and severity of the solicited (terms pre-listed in the Case Report Form [CRF]) injection site and systemic reactions between D0 and D7 after each injection.
3) The occurrence, nature (MedDRA preferred term), time to onset, duration, severity and relationship to vaccination of unsolicited (spontaneously reported) AEs from vaccination day to next study visit.
4) The occurrence, nature (MedDRA preferred term), time to onset, duration, relationship to vaccination, outcome, seriousness of any Serious Adverse Event (SAE) occurring throughout the trial. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Immunogenicity:
1) One month after booster vaccination in both groups (at V04/D210):
Safety:
1) 30 minutes after each vaccination
2) Day 0 and Day 7 after each injection
3) Vaccination day to next study visit
4) Throughout the trial |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 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 months | 8 |