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 |
To describe the safety of Avaxim 80U Pediatric vaccine after each dose of vaccine administered 6 months apart, in subjects aged 12 months to 15 years. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment: 1) Aged 12 to 185 months (approximately 15 years and 5 months) on the day of inclusion 2) Informed consent form has been signed and dated by the subject aged 12 years old and above (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative 3) Subject and parent/legally acceptable representative are able to attend all schedule visits and to comply with all trial procedures 4) Subjects aged less than 2 years only: Born at fu ll term of pregnancy (≥ 37 weeks) and/or with a birth weight ≥ 2.5 kg. |
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E.4 | Principal exclusion criteria |
An individual fulfilling any of the following criteria was to be excluded from trial enrollment: 1) Subject is pregnant, or lactating, or o f childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after the last vaccination) 2) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure 3) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination 4) Previous vaccination against Hepatitis A with either the trial vaccine or another Hepatitis A vaccine 5) Receipt of immune globulins, blood or blood-derived products in the past 3 months 6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) 7) History of Hepatitis A infection, confirmed either clinically, serologically, or microbiologically 8) At high risk for Hepatitis A infection during the trial 9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances 10) Self-reported thrombocytopenia, contraindicating IM vaccination 11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination 12) Deprived of freedom by an administrative or court order, o r in an emergency setting, or hospitalized involuntarily 13) Current alcohol abuse or drug addiction 14) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 15) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided 16) Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1) Occurrence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each vaccination 2) Occurrence of any solicited (terms pre-listed in the subject’s diary card [DC] and case report form [CRF]) injection site and systemic reactions occurring up to 7 days (D7) after each vaccination 3) Occurrence of unsolicited (spontaneously reported) AEs occurring up to 30 days (D30) after vaccination 4) Occurrence of any serious adverse events (SAEs) up to D30 after each vaccination and occurrence of related SAEs or deaths between D30 and the second vaccination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) Within 30 minutes of vaccination 2) Day 0 up to Day 7 post-each vaccination 3) Day 0 up to Day 30 post-vaccination 4) Day 0 up to Day 30 post-each vaccination |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
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 | 7 |