| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (Booster immunisation of healthy children in the second year of life against diphtheria, tetanus, pertussis and Haemophilus influenzae type b diseases). |
|
| E.1.1.1 | Medical condition in easily understood language |
| Diphtheria, tetanus, pertussis and Haemophilus influenza type b |
|
| 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 evaluate the immune response to all vaccine antigens, i.e. diphtheria and tetanus toxoids, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN), and polyribosyl-ribitol-phosphate (PRP), one month after booster vaccination with the DTPa/Hib vaccine or with the DTPa and Hib vaccines administered separately. |
|
| E.2.2 | Secondary objectives of the trial |
•To evaluate the persistence of antibodies to all vaccine antigens at the pre-booster time point in subjects previously vaccinated with three doses of the DTPa/Hib vaccine or with three doses of the DTPa and Hib vaccines administered separately.
•To evaluate the safety and reactogenicity of a booster dose of the DTPa/Hib vaccine and the separately administered DTPa and Hib vaccines in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs) during the study period.
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
•Subjects should have completed the full three-dose primary vaccination course in study DTPa-131 (104567).
•A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study. |
|
| E.4 | Principal exclusion criteria |
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding booster vaccination, or planned use 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 booster dose. For corticos-teroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of measles or combined measles, mumps and rubella (MMR) vaccination.
•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).
•Previous booster vaccination against diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases since the end of the primary study.
•History of diphtheria, tetanus, pertussis and/or Haemophilus influenzae type b diseases.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•A family history of congenital or hereditary immunodeficiency.
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
•Major congenital defects or serious chronic illness.
•History of any progressive neurological disorders or seizures.
•Acute disease and/or fever at time of enrolment warrants a deferral of the vaccination pending recovery of the subject. Fever is defined as axillary temperature greater than or equal to 37.1°C.
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
•Occurrence of any of the following adverse events (AEs) after previous administration of a DTP vaccine:
-Hypersensitivity reaction due to any component of the 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, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
-Fever greater than or equal to 40.0 °C (axillary temperature) within 48 hours of vaccination.
-Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
-Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting greater than or equal to 3 hours.
-Seizures with or without fever occurring within 3 days of vaccination. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
Immunogenicity:
•Anti-PRP antibody concentrations greater than or equal to 0.15 µg/ml and greater than or equal to 1.0 µg/ml.
•Anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/ml and greater than or equal to 1.0 IU/ml.
•Anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/ml.
•Anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to 20 EL.U/ml.
•Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA, and anti-PRN antibody concentrations |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| One month after booster vaccination. |
|
| E.5.2 | Secondary end point(s) |
Immunogenicity:
•Anti-PRP antibody concentration greater than or equal to 0.15 µg/ml and greater than or equal to 1.0 µg/ml.
•Anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/ml and greater than or equal to 1.0 IU/ml.
•Anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/ml.
•Anti-PT, anti-FHA and anti-PRN antibody concentrations greater than or equal to 20 EL.U/ml.
•Anti-PRP, anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
| Before booster vaccination |
|
| 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 | Yes |
| 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 | Yes |
| 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 | 2 |
| 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 |
|
| 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
|
|
| 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 | 1 |
| E.8.9.2 | In all countries concerned by the trial days | 20 |
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