| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Subjects who participated in booster study 10PN-PD-DiT-007 in Poland and who received the full vaccination course (i.e. four doses) with a pneumococcal vaccine, co-administered with DTPa-HBV-IPV/Hib, will be followed-up to evaluate the long-term persistence of antibodies at approximately 30, 42 and 66 months of age and will be vaccinated in the 6th year of life against Streptococcus pneumoniae in parallel with age-matched unprimed subjects. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10061353 |
| E.1.2 | Term | Pneumococcal infection |
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| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10061190 |
| E.1.2 | Term | Haemophilus infection |
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| 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 antibody persistence 1 year post booster (12 to 14 months), 2 years post booster (24 to 26 months) and 4 years post booster (48 to 50 months) following a four dose vaccination course with a pneumococcal conjugate vaccines |
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| E.2.2 | Secondary objectives of the trial |
To assess immunological memory 4 years following a four dose vaccination course with a pneumococcal conjugate vaccine in the first two years of life.
To evaluate the immunogenicity, safety and reactogenicity of the 10Pn-PD-DiT vaccine following a 2-dose catch-up vaccination in the sixth year of life. |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
All subjects must satisfy the following criteria at Visit 1 for the study on long-term follow-up of antibody persistence:
•Male or female between, and including, 28-32 months of age at the time of first blood sampling.
•Subjects who previously participated in the 10PN-PD-DIT-001 and the 10PN-PD-DIT-007 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
•Written informed consent, covering Visits 1, 2 and 3, obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study
All subjects must satisfy the following criteria at Visits 2 and 3:
•Subject must have participated in Visit 1.
All subjects must satisfy the following criteria at Visit 3 for primed subjects or at study entry for unprimed subjects for the study on assessment of immunological memory
•Written informed consent obtained from the parent or guardian of the subject.
•Male or female between, and including, 64-68 months of age at the time of vaccination or dose 1, as applicable.
•Subjects for whom 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).
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•For primed subjects: Having completed the long-term follow-up for antibody persistence in studies 10PN-PD-DIT-041 BST:007 Y1, Y2 and Y4.
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| E.4 | Principal exclusion criteria |
The following criteria should be checked at Visit 1 of the long-term follow study for antibody persistence. If any apply, the subject must not be included in the study:
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling. (For corticosteroids, this will mean prednisone, or equivalent, higher or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Administration of any additional pneumococcal vaccine since end of 10PN-PD-DIT-007 study.
•Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
•Administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling.
•Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 10Pn-PD-DIT-007 study, based on medical history and physical examination (no laboratory testing required).
The following criteria should be checked at Visit 3 for primed subjects or at study entry for unprimed subjects. If any apply, unprimed subjects must not be included in the study and primed subjects must not participate in study procedures for assessment of immunological memory:
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination or first dose of study vaccine, as applicable, or planned use during the study period.
•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).
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination or first dose of study vaccine, as applicable. (For corticosteroids, this will mean prednisone, or equivalent, higher or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or first dose of study vaccine, as applicable, or planned administration during the study period.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before and ending 30 days after vaccination or each dose of study vaccine, as applicable, with the exception of locally recommended vaccines (recommended through national immunization campaigns) such as influenza vaccines.
•Administration of any pneumococcal vaccine outside studies 10PN-PD-DIT-001 (105553) and 10PN-PD-DIT-007 (107046).
•For unprimed subjects: previous vaccination with any pneumococcal vaccine.
•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.
•Major congenital defects or serious chronic illness.
•History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included).
•Acute disease at the time of enrolment. (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, mild upper respiratory infection, provided the body temperature is < 38.0°C (rectal measurement) or < 37.5°C (oral/axillary/tympanic measurements). The 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) |
Immunogenicity:
At the defined timepoints for all subjects:
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations higher or equal to 0.05 µg/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 | No |
| 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) | 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) | 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 | 6 |
| 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
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 4 |
| E.8.9.1 | In the Member State concerned months | 1 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 4 |
| 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 | 0 |
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