E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects aged 31-44 months previously vaccinated with GSK Biologicals’ 10Pn-PD-DiT vaccine and age-matched unprimed children who participated in study 10PN-PD-DIT-014 (107137). |
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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 demonstrate the immunological memory induced following primary vaccination in study 10PN-PD-DIT-010 (107017) and booster vaccination in study 10PN-PD-DIT-014 (107137) with the 10Pn-PD-DiT vaccine, through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, compared to the unprimed group. Criteria for immune memory: The immune memory will be demonstrated if the lower limit of the 95% CI around the GMC ratios (pooled primed groups over unprimed group) is higher than 1 for all 10 vaccine serotypes.
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E.2.2 | Secondary objectives of the trial |
Antibody persistence 25-36 months after the last 10Pn-PD-DiT vaccine dose administered at 12-15 months of age in study 107137 Long-term effects of the 10Pn-PD-DiT vaccine on nasopharyngeal carriage 16-32 months and 25-36 months following the last vaccine dose administered at 12-15 months of age in study 107137 Antibody persistence 25-36 months after vaccination with MenACWY-TT conjugate vaccine in study 107137 Immunogenicity of 10Pn-PD-DiT vaccine when given as a 2-dose catch-up vaccination course to the unprimed children that participated in study 107137 in their fourth year of life Safety/reactogenicity of 10Pn-PD-DiT vaccine when given as a 2-dose catch-up vaccination course to the unprimed children that participated in study 107137 in their fourth year of life Safety/reactogenicity of an additional booster dose of 10Pn-PD-DiT vaccine administered at 40-48 months of age in children previously vaccinated with 10Pn-PD-DiT vaccine at 12-15 months of age in study 107137 |
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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 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. A male or female between, and including, 31 and 44 months of age at the time of the enrolment. Subjects who previously participated in study 10PN-PD-DIT-014 (107137): *For the subjects in the primed AP-AP and NAP-pre groups: subjects who received a booster dose of the pneumococcal conjugate vaccine prior to the 10PN-PD-DIT-014 study amendment 3. *For the subjects in the unprimed group: subjects who received a dose of the MenACWY-TT vaccine. Written informed consent 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.
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E.4 | Principal exclusion criteria |
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding enrolment, or planned use during the entire study period. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the entire study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed). Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. 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). Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease. Acute disease at the time of enrolment, defined as the presence of a mild, moderate or severe illness with or without fever. Administration or planned use of immunoglobulins and/ or any blood products during the entire study period. A family history of congenital or hereditary immunodeficiency. Major congenital defects or serious chronic illness. Subjects of which both parents have a history of atopia (polinosis, asthma, atopic eczema). Administration of any pneumococcal vaccine since the end of study 10PN-PD-DIT-014 (107137). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Demonstration of immune responses to components of the investigational vaccine, 7-10 days after the single/first dose of investigational vaccine: *Concentrations of antibodies against vaccine pneumococcal serotypes.
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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 | 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 | 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 | 10 |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |