E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
challenge dose of Engerix B to assess the quality of the persisting immune memory against hepatitis B in children aged 6 to 7 years |
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E.1.1.1 | Medical condition in easily understood language |
challenge dose of Engerix B to assess the quality of the persisting immune memory against hepatitis B in children aged 6 to 7 years |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019731 |
E.1.2 | Term | Hepatitis B |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 persistence of anti-hepatitis B surface (HBs) antibodies at 6 to 7 years of age in subjects having received an hexavalent vaccine at 3, 5 and 11 to 12 months of age according to the vaccine received during Study A3L38 (Hexyon [Group 1] or Infanrix hexa [Group 2])
-To evaluate the immune response against HBs antigen one month after a vaccination with a standalone monovalent HB vaccine (challenge dose)
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E.2.2 | Secondary objectives of the trial |
-To describe serious adverse events (SAEs) reported throughout the study |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Aged 6 to 7 years on the day of vaccination ("6 to 7 years" means from the day of the 6th birthday to the day before the 8th birthday).
-Informed Consent Form (ICF) has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed by the subject able to read.
-Receipt of 3 doses of either Hexyon or Infanrix hexa vaccine at the age of 3, 5, and 11 to 12 months in Study A3L38 with a post-dose 3 anti-hepatitis B (HB)s antibody titer available.
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E.4 | Principal exclusion criteria |
-Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
-Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following study vaccination except for influenza vaccination, which may be received less than 4 weeks before study vaccine.
-Subject known to have received HB containing vaccine after completion of Study A3L38 procedures.
-Receipt of immune globulins, blood or blood-derived products in the past 3 months.
-Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
-History or diagnosis of an of HB infection, confirmed either clinically, serologically, or microbiologically after completion of Study A3L38 procedures.
-Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the study or to a vaccine containing any of the same substances.
-Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
-Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
-Some criteria are temporarily exclusion criteria. In case a subject meets any of these criteria, a further appointment will be scheduled to reassess the subject’s eligibility.
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E.5 End points |
E.5.1 | Primary end point(s) |
Individual anti-hepatitis B surface (HBs) antibody concentrations
Individual anti-HBs antibody concentration ratios (one month post-/pre-vaccination)
Individual anti-HBs antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL
Anamnestic response rate
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and/or Day 28 (post-vaccination) |
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E.5.2 | Secondary end point(s) |
Occurrence of Serious Adverse Events (SAEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline to Day 28 (post-vaccination) |
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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 | Yes |
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 | 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.8.3 |
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 | 10 |
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 | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |