E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) diseases. |
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E.1.1.1 | Medical condition in easily understood language |
Diphtheria, tetanus (lock jaw), pertussis (Whooping cough), Polio and Haemophilus influenza type |
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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 persistence of antibodies to all vaccine antigens before the booster dose.
•To assess the immune response to the study vaccines in terms of seroprotection to diphtheria, tetanus, Haemophilus influenzae type b and poliovirus types 1, 2 and 3, and in terms of vaccine response to the pertussis antigens, one month after booster vaccination.
•To assess the immune response to the study vaccines in terms of antibody concentrations or titres for all antigens, one month after the booster dose.
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E.2.2 | Secondary objectives of the trial |
•To assess the safety and reactogenicity of the booster dose of the study vaccines in terms of solicited and unsolicited, local and general symptoms and serious adverse events. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
•Subjects who completed the full three-dose primary vaccination course in the DTPA-IPV-056 (112584) study.
•Subjects who the investigator believes that their parent(s)/ LAR(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit).
•Written informed consent obtained from the parent(s)/LAR(s) of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study. |
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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 vaccines within 30 days preceding the booster dose of the 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 the booster dose. 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 vaccination, or planned administration during the study period.
•Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Hib, vaccination or disease since the con-clusion visit of primary study DTPA-IPV-056 (112584).
•Serious chronic illness.
•Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
•Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine.
-Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
-Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
-Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
-Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
-Seizures with or without fever occurring within 3 days of vaccination.
•The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
Acute disease and/or fever at the time of enrolment.
-Fever is defined as temperature ≥ 37.1°C on oral, axillary or tympanic setting, or ≥ 37.6°C on rectal setting. 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers.
•Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers.
-Vaccine response to the pertussis antigens.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
•Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers-Month 0.
•Anti-diphtheria, anti-tetanus, anti-PRP, anti-poliovirus type 1, 2 and 3, anti-PT, anti-FHA and anti-PRN seroprotection and/or seropositivity status and antibody concentrations or titers-At Month 0 and Month 1.
-Vaccine response to the pertussis antigens-Month 1. |
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E.5.2 | Secondary end point(s) |
-Occurrence of solicited local and general symptoms.
-Occurrence of unsolicited adverse events.
-Occurrence of serious adverse events. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Occurrence of solicited local and general symptoms-During the 4-day (Day 0-3) follow-up period following the booster dose of the study vaccine.
-Occurrence of unsolicited adverse events-During the 31-day (Day 0-30) follow-up period following the booster dose of the study vaccine.
-Occurrence of serious adverse events-From Month 0 to Month 1. |
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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 | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |