E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Antibody persistence and hepatitis B vaccine challenge at 11-12 years of age (excluding 13th birthday), after primary vaccination with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or GSK Biologicals’ HBV vaccine (Engerix-B) given at the ages of 3, 5 and 11 months. |
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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 assess the anti-HBs antibody response to a challenge dose of HBV vaccine in subjects aged 11-12 years, vaccinated in infancy with three doses of Infanrix hexa or Engerix-B at 3, 5 and 11 months of age. |
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E.2.2 | Secondary objectives of the trial |
•To assess the persistence of anti-HBs antibodies, 10-11 years after primary infant vaccination with three doses of Infanrix hexa or Engerix-B at 3, 5 and 11 months of age. •To evaluate the safety and reactogenicity of a challenge dose of HBV vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All subjects must satisfy ALL the following criteria at study entry: •Subjects who the investigator believes that their parents/LAR(s) can and will comply with the requirements of the protocol (return for follow-up visits) should be enrolled in the study. •A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday). •Written informed consent obtained from the parent or LAR of the subject. •Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator. •Written informed assent obtained from the subject (the study purpose and procedures will be explained to the subject by appropriately trained personnel) in addition to the informed consent signed by the parent(s)/LAR(s). •Healthy subjects as established by medical history and clinical examination before entering into the study. •Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study DTPa-HBV-IPV-031. •Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. •Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
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E.4 | Principal exclusion criteria |
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study: •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). •Child in care. •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period. •Receipt of hepatitis B (containing) vaccine after vaccination in the primary study DTPa-HBV-IPV-031. •History of hepatitis B disease. •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose. •Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period. •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine. For corticosteroids, this will mean prednisone <20 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed. •Pregnant or lactating female. •Female planning to become pregnant or planning to discontinue contraceptive precautions. •Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component. •Acute disease and/or fever at the time of enrolment. •Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
•Anti-HBs antibody concentrations one month after a challenge dose of HBV vaccine: Percentage of subjects with anti-HBs antibody concentrations greater than or equal to 100 mIU/ml.
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 12 |
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 | Information not present in EudraCT |
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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The end of the trial is defined as one month after the administration of the booster dose. |
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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 | 7 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 15 |