E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Measles
Mumps
Rubella
Hepatitis A |
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E.1.1.1 | Medical condition in easily understood language |
Measles
Mumps
Rubella
Hepatitis A
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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 compare the immunogenicity of AVAXIM 80U-Pediatric vaccine administered in hepatitis A virus (HAV) seronegative children aged 12 to 13 months alone or in association with TRIMOVAX vaccine at 2 different sites, in terms of percentage of seroprotected subjects (titer ≥20 mIU/mL) 4 weeks after the first dose (D28). |
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E.2.2 | Secondary objectives of the trial |
Immunogenicity*
1) To describe the immunogenicity of AVAXIM 80U-Pediatric vaccine on D28, in terms of geometric mean of titers (GMT) when given alone or in association with TRIMOVAX vaccine.
2) To describe the immunogenicity of AVAXIM 80U-Pediatric vaccine 4 weeks after the booster dose (D243) in terms of percentage of seroprotected subjects (titers ≥20 mIU/mL).
3) To describe the immunogenicity of TRIMOVAX vaccine 4 weeks after vaccination (D28) in terms of percentage of seroconversion to the 3 valences (MMR) and in terms of GMT of anti-measles, anti-mumps, and anti-rubella antibodies pre- and post-vaccination, when given alone or in association with
AVAXIM 80U-Pediatric vaccine.
* anti-HAV Abs were measured by commercially available Axsym HAVAB 2.0 kit (Abbott)
Safety
1) To describe the safety of AVAXIM 80U-Pediatric and TRIMOVAX vaccines. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Aged 12-13 months on the day of inclusion
2) Born at full term of pregnancy (>37 weeks) with a birth weight ≥ 2.5 kg
3) Informed consent form signed by the parent(s) or other legal representative
4) Able to attend all scheduled visits and to comply with all trial procedures
5) Subjects having received only one or no injection of vaccine against Measles
6) Subjects anti-HAV seronegative according to the results obtained at the screening visit* |
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E.4 | Principal exclusion criteria |
1) Participation in another clinical trial in the 4 weeks preceding the (first) 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 first trial vaccination
8) Vaccination planned in the 4 weeks following any trial vaccination
9) History of hepatitis A, Mumps, Measles and/or Rubella infection (confirmed either clinically, serologically or microbiologically)
10) Previous vaccination against hepatitis A with the trial vaccine or another vaccine
11) Previous vaccination against Mumps, Measles and Rubella with a Mumps, Measles and Rubella trivalent combined vaccine
12) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
13) History of seizures
14) Febrile illness (axillary temperature ≥37.4°C]) on the day of inclusion |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) To provide information concerning the immunogenicity of Hepatitis A Vaccine in subjects receiving Pediatric vaccines |
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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) |
1) Individual titers ratio post/pre-dose 1 (BL2/BL1) and post/pre-booster (BL4/BL3).
2) Seroprotection, defined as anti-HAV Ab titer ≥20 mIU/mL on D213 and D243. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Day 28/Day 7 and Day 243/Day 213
2) Day 213 and Day 243 |
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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) | 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 | Yes |
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 |
Live attenuated MMR vaccine |
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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 | 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 |