E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Booster immunisation against diphtheria, tetanus and pertussis diseases in healthy children aged four years and above. |
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E.1.1.1 | Medical condition in easily understood language |
Diphtheria, tetanus (lock jaw) and pertussis (Whooping cough). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
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 safety and reactogenicity of the study vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs). |
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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 |
•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•A male or female between, and including, 6 and 10 years of age at the time of the vaccination (from and including the 6th birthday up to but excluding the 11th birthday).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Written informed assent to be obtained from the subject in addition to the informed consent signed by the par-ent(s)/LAR(s), as required by local regulations.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Subjects who have previously completed their routine vaccinations against diphtheria, tetanus and pertussis diseases according to the local recommended vaccination schedule at that time and have not received the vaccine in the last two years prior to study dose administration.
•Female subjects of non-childbearing potential may be enrolled in the study.
-Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
-has practiced abstinence or 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 |
•Child in care.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
•Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune modifying drugs within six months prior to vaccination. (For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccine dose, or planned administration during the study period.
•Administration of immunoglobulins and/or any blood products within the three months preceding Visit 1 or planned administration during the study period.
•Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
•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).
•A history of previous or intercurrent diphtheria, tetanus or pertussis disease.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•Major congenital defects or serious chronic illness.
•Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting or 38.0°C on rectal set-ting. The preferred route for recording temperature in this study will be axillary.
-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
•Pregnant or lactating female. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety and reactogenicity after booster vaccination
-Occurrence of each solicited local and general symptom.
-Occurrence of unsolicited symptoms.
-Occurrence of Serious adverse events. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
-Occurrence of each solicited local and general symptom-During the 4-day (Day 0-3) follow-up period after booster vaccination.
-Occurrence of unsolicited symptoms-During the 31-day (Day 0-30) follow-up period after booster vaccination.
-Occurrence of Serious adverse events-From the receipt of booster dose up to study end. |
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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 | 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 | 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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |