E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
A booster vaccination study against Streptococcus pneumoniae in subjects aged 36-46 months and a two-dose vaccination against Streptococcus pneumoniae of age-matched unprimed children. |
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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 immune responses following vaccination with a booster dose of the 10Pn-PD-DiT vaccine administered at 36-46 months of age in children previously vaccinated with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539) according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age and to assess the immune responses following vaccination with a single dose of the 10Pn-PD-DiT vaccine in age-matched unprimed children. |
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E.2.2 | Secondary objectives of the trial |
To assess the antibody persistence 24-34 months following vaccination in study 10PN-PD-DIT-002 (105539) with the 10Pn-PD-DiT vaccine according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age. To evaluate the safety, reactogenicity and immunogenicity of the 10Pn-PD-DiT vaccine when given as a 2-dose vaccination course to unprimed children in their fourth year of life. To assess the safety and reactogenicity of a booster dose of the 10Pn-PD-DiT vaccine administered at 36-46 months of age in children previously vaccinated with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539) according to either a 3-dose or 2-dose primary vaccination within the first 6 months of age and booster vaccination at 11 months of age.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female between, and including, approximately 36-46 months of age at the time of vaccination. For primed subjects: having completed the full vaccination course with the 10Pn-PD-DiT vaccine in study 10PN-PD-DIT-002 (105539). Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). Written informed consent obtained from the parent(s)/guardian(s) of the subject. Free of obvious health problems as established by medical history and clinical examination before entering into the study.
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E.4 | Principal exclusion criteria |
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination or planned use during the study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccination. (For corticosteroids, this will mean prednisone, or equivalent, equal or above 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) For primed subjects: administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-002 (105539). For unprimed subjects: previous vaccination with any pneumococcal vaccine. Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned use during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of reactions or allergic disease likely to be exacerbated by any component of the study vaccine. Acute disease at the time of vaccination (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infection, provided the body temperature is <38°C (rectal measurement) or <37.5°C (for oral/axillary/tympanic measurements). Study entry should be delayed until the illness has improved).
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E.5 End points |
E.5.1 | Primary end point(s) |
Concentrations of antibodies against vaccine pneumococcal serotypes, 7-10 days after immunization or dose 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 | 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 | 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) | 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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |